Trial Outcomes & Findings for Tinnitus Retraining Therapy Trial (NCT NCT01177137)

NCT ID: NCT01177137

Last Updated: 2018-11-21

Results Overview

The TQ is a tinnitus-specific health-related quality of life instrument with 52 statements that the respondent marks as true, partly true, or not true. The TQ is scored from 0 to 102, with higher scores indicating more of an impact of the tinnitus on quality of life. Subscales include emotional distress, intrusiveness, auditory perceptual difficulties, sleep disturbance,and somatic complaints.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 151 participants
• Primary outcome timeframe: Baseline to 3, 6, 12, and 18 months follow-up
• Results posted on: 2018-11-21

Participant Flow

Participant milestones

Measure	Tinnitus Retraining Therapy (TRT) TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Overall Study STARTED	51	51	49
Overall Study COMPLETED	41	41	47
Overall Study NOT COMPLETED	10	10	2

Reasons for withdrawal

Measure	Tinnitus Retraining Therapy (TRT) TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Overall Study Withdrawal by Subject	10	10	2

Baseline Characteristics

Tinnitus Retraining Therapy Trial

Baseline characteristics by cohort

Measure	Tinnitus Retraining Therapy (TRT) n=51 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=51 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=49 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.	Total n=151 Participants Total of all reporting groups
Age, Continuous	51.1 years STANDARD_DEVIATION 12.6 • n=5 Participants	50.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	49.9 years STANDARD_DEVIATION 10.6 • n=5 Participants	50.6 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	13 Participants n=5 Participants	44 Participants n=4 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	37 Participants n=7 Participants	36 Participants n=5 Participants	107 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	18 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	39 Participants n=7 Participants	35 Participants n=5 Participants	110 Participants n=4 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	41 Participants n=5 Participants	44 Participants n=7 Participants	41 Participants n=5 Participants	126 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or not reported	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Marital status Married/living with partner	39 Participants n=5 Participants	41 Participants n=7 Participants	41 Participants n=5 Participants	121 Participants n=4 Participants
Marital status Single/never married	4 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants
Marital status Divorced/separated	7 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	15 Participants n=4 Participants
Marital status Widowed	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Marital status Other/unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Smoking status Current smoker	0 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Smoking status Previous smoker	15 Participants n=5 Participants	15 Participants n=7 Participants	11 Participants n=5 Participants	41 Participants n=4 Participants
Smoking status Never smoked	36 Participants n=5 Participants	33 Participants n=7 Participants	36 Participants n=5 Participants	105 Participants n=4 Participants
Duration of tinnitus as a problem Less than 2 years	12 Participants n=5 Participants	11 Participants n=7 Participants	6 Participants n=5 Participants	29 Participants n=4 Participants
Duration of tinnitus as a problem More than 2 years but less than 5 years	15 Participants n=5 Participants	17 Participants n=7 Participants	20 Participants n=5 Participants	52 Participants n=4 Participants
Duration of tinnitus as a problem More than 5 years	24 Participants n=5 Participants	22 Participants n=7 Participants	22 Participants n=5 Participants	68 Participants n=4 Participants
Duration of tinnitus as a problem Unknown/missing	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Tinnitus type of sound Tonal (ringing, music, whistling, etc.)	47 Participants n=5 Participants	47 Participants n=7 Participants	47 Participants n=5 Participants	141 Participants n=4 Participants
Tinnitus type of sound Low frequency (buzzing, puldating, ocean, etc.	4 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	7 Participants n=4 Participants
Tinnitus type of sound High frequency (hissing, sizzling, ectc.)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Tinnitus type of sound Other (clicking, crickets, etc.)	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Tinnitus type of sound Missing	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Tinnitus location One ear	11 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Tinnitus location Both ears	22 Participants n=5 Participants	24 Participants n=7 Participants	20 Participants n=5 Participants	66 Participants n=4 Participants
Tinnitus location In the head	7 Participants n=5 Participants	11 Participants n=7 Participants	10 Participants n=5 Participants	28 Participants n=4 Participants
Tinnitus location In the head and one or both ears	11 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants	38 Participants n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Total	56.4 units on a scale STANDARD_DEVIATION 11.9 • n=5 Participants	54.4 units on a scale STANDARD_DEVIATION 11.5 • n=7 Participants	54.6 units on a scale STANDARD_DEVIATION 11.2 • n=5 Participants	55.1 units on a scale STANDARD_DEVIATION 11.5 • n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Auditory perceptual	7.2 units on a scale STANDARD_DEVIATION 2.8 • n=5 Participants	7.1 units on a scale STANDARD_DEVIATION 3.0 • n=7 Participants	7.7 units on a scale STANDARD_DEVIATION 3.7 • n=5 Participants	7.3 units on a scale STANDARD_DEVIATION 3.1 • n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Emotional distress	17.2 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants	17.0 units on a scale STANDARD_DEVIATION 6.6 • n=7 Participants	15.8 units on a scale STANDARD_DEVIATION 5.5 • n=5 Participants	16.7 units on a scale STANDARD_DEVIATION 6.1 • n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Intrusiveness	9.9 units on a scale STANDARD_DEVIATION 2.0 • n=5 Participants	9.9 units on a scale STANDARD_DEVIATION 2.1 • n=7 Participants	9.8 units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants	9.9 units on a scale STANDARD_DEVIATION 2.0 • n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Sleep disturbance	4.9 units on a scale STANDARD_DEVIATION 2.3 • n=5 Participants	4.3 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	4.8 units on a scale STANDARD_DEVIATION 2.4 • n=5 Participants	4.7 units on a scale STANDARD_DEVIATION 2.3 • n=4 Participants
Baseline scores on the Tinnitus Questionnaire and sub-scales Somatic complaint	5.3 units on a scale STANDARD_DEVIATION 1.6 • n=5 Participants	4.5 units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	4.9 units on a scale STANDARD_DEVIATION 1.7 • n=5 Participants	4.9 units on a scale STANDARD_DEVIATION 1.7 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Total	48.1 units on a scale STANDARD_DEVIATION 17.6 • n=5 Participants	50.3 units on a scale STANDARD_DEVIATION 17.1 • n=7 Participants	53.5 units on a scale STANDARD_DEVIATION 17.3 • n=5 Participants	50.6 units on a scale STANDARD_DEVIATION 17.3 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Auditory difficulties	45.1 units on a scale STANDARD_DEVIATION 27.2 • n=5 Participants	45.0 units on a scale STANDARD_DEVIATION 27.2 • n=7 Participants	46.6 units on a scale STANDARD_DEVIATION 25.7 • n=5 Participants	45.6 units on a scale STANDARD_DEVIATION 25.9 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Cognitive interference	42.7 units on a scale STANDARD_DEVIATION 21.2 • n=5 Participants	51.0 units on a scale STANDARD_DEVIATION 22.1 • n=7 Participants	47.8 units on a scale STANDARD_DEVIATION 24.5 • n=5 Participants	47.2 units on a scale STANDARD_DEVIATION 22.7 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Emotional distress	31.6 units on a scale STANDARD_DEVIATION 24.6 • n=5 Participants	31.8 units on a scale STANDARD_DEVIATION 26.1 • n=7 Participants	34.4 units on a scale STANDARD_DEVIATION 23.6 • n=5 Participants	32.6 units on a scale STANDARD_DEVIATION 24.7 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Intrusiveness	63.3 units on a scale STANDARD_DEVIATION 23.2 • n=5 Participants	67.5 units on a scale STANDARD_DEVIATION 18.0 • n=7 Participants	70.7 units on a scale STANDARD_DEVIATION 17.3 • n=5 Participants	67.1 units on a scale STANDARD_DEVIATION 19.8 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Reduced sense of control	58.6 units on a scale STANDARD_DEVIATION 20.9 • n=5 Participants	63.7 units on a scale STANDARD_DEVIATION 16.7 • n=7 Participants	67.8 units on a scale STANDARD_DEVIATION 19.5 • n=5 Participants	63.3 units on a scale STANDARD_DEVIATION 19.3 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Reduced quality of life	30.1 units on a scale STANDARD_DEVIATION 22.7 • n=5 Participants	35.7 units on a scale STANDARD_DEVIATION 23.1 • n=7 Participants	37.0 units on a scale STANDARD_DEVIATION 25.4 • n=5 Participants	34.2 units on a scale STANDARD_DEVIATION 23.8 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Relaxation difficulties	63.9 units on a scale STANDARD_DEVIATION 23.6 • n=5 Participants	61.9 units on a scale STANDARD_DEVIATION 27.2 • n=7 Participants	68.2 units on a scale STANDARD_DEVIATION 24.4 • n=5 Participants	64.6 units on a scale STANDARD_DEVIATION 25.1 • n=4 Participants
Baseline scores on Tinnitus Functional Index and sub-scales Sleep disturbance	55.4 units on a scale STANDARD_DEVIATION 30.8 • n=5 Participants	50.3 units on a scale STANDARD_DEVIATION 28.1 • n=7 Participants	61.0 units on a scale STANDARD_DEVIATION 30.2 • n=5 Participants	55.5 units on a scale STANDARD_DEVIATION 29.8 • n=4 Participants
Baseline scores on the Tinnitus Handicap Inventory and sub-scales Total	37.8 units on a scale STANDARD_DEVIATION 13.0 • n=5 Participants	42.3 units on a scale STANDARD_DEVIATION 20.7 • n=7 Participants	38.6 units on a scale STANDARD_DEVIATION 16.7 • n=5 Participants	39.6 units on a scale STANDARD_DEVIATION 17.1 • n=4 Participants
Baseline scores on the Tinnitus Handicap Inventory and sub-scales Functional subscale	18.4 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants	20.9 units on a scale STANDARD_DEVIATION 9.5 • n=7 Participants	19.3 units on a scale STANDARD_DEVIATION 8.4 • n=5 Participants	19.5 units on a scale STANDARD_DEVIATION 8.2 • n=4 Participants
Baseline scores on the Tinnitus Handicap Inventory and sub-scales Emotional subscale	11.3 units on a scale STANDARD_DEVIATION 6.2 • n=5 Participants	12.7 units on a scale STANDARD_DEVIATION 9.0 • n=7 Participants	11.4 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants	11.8 units on a scale STANDARD_DEVIATION 7.5 • n=4 Participants
Baseline scores on the Tinnitus Handicap Inventory and sub-scales Catastrophic subscale	8.2 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants	8.7 units on a scale STANDARD_DEVIATION 4.2 • n=7 Participants	8.0 units on a scale STANDARD_DEVIATION 3.5 • n=5 Participants	8.3 units on a scale STANDARD_DEVIATION 3.7 • n=4 Participants
Rank of tinnitus as problem	6.2 units on a scale STANDARD_DEVIATION 2.2 • n=5 Participants	6.4 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	6.3 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants	6.3 units on a scale STANDARD_DEVIATION 2.2 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

The TQ is a tinnitus-specific health-related quality of life instrument with 52 statements that the respondent marks as true, partly true, or not true. The TQ is scored from 0 to 102, with higher scores indicating more of an impact of the tinnitus on quality of life. Subscales include emotional distress, intrusiveness, auditory perceptual difficulties, sleep disturbance,and somatic complaints.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 3 months	-17.8 units on a scale Standard Deviation 13.6	-15.4 units on a scale Standard Deviation 15.9	-11.5 units on a scale Standard Deviation 13.4
Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 6 months	-22.0 units on a scale Standard Deviation 15.6	-18.3 units on a scale Standard Deviation 15.4	-14.5 units on a scale Standard Deviation 14.8
Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 12 months	-21.1 units on a scale Standard Deviation 15.1	-21.8 units on a scale Standard Deviation 15.9	-17.6 units on a scale Standard Deviation 14.0
Change in Tinnitus Questionnaire (TQ) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 18 months	-18.2 units on a scale Standard Deviation 15.2	-19.0 units on a scale Standard Deviation 15.9	-16.5 units on a scale Standard Deviation 16.3

SECONDARY outcome

Timeframe: Baseline and 3, 6, 12, and 18 months

Population: Intention to treat, including data from all participants with at least one follow-up visit

The TFI is a tinnitus-specific health -related quality of life instrument. Subscales include intrusiveness, reduced sense of control, cognitive interference, sleep disturbance, auditory difficulties (related to tinnitus), relaxation interference, reduced quality of life, and emotional distress. The total and each subscale score ranges from 0 to 100 with higher scores indicated a greater impact of tinnitus on quality of life.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 3 months	-3.7 units on a scale Standard Deviation 15.3	-10.9 units on a scale Standard Deviation 18.0	-4.4 units on a scale Standard Deviation 12.7
Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 6 months	-9.6 units on a scale Standard Deviation 14.2	-9.5 units on a scale Standard Deviation 18.6	-8.7 units on a scale Standard Deviation 18.0
Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 12 months	-7.7 units on a scale Standard Deviation 18.6	-17.2 units on a scale Standard Deviation 17.7	-16.3 units on a scale Standard Deviation 19.2
Change in Tinnitus Functional Index (TFI) From Baseline to 3, 6, 12, and 18 Months Change from baseline to 18 months	-6.7 units on a scale Standard Deviation 18.5	-14.4 units on a scale Standard Deviation 17.2	-10.3 units on a scale Standard Deviation 21.9

SECONDARY outcome

Timeframe: Baseline and 3. 6. 12. and 18 months

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in THI score from baseline to 3 months follow-up. The THI is a tinnitus-specific health-related quality of life instrument. Subscales include the functional (scored 0 to 44), emotional (scored 0 to 36) and catastrophic (scored 0 to 20). The total score ranges from 0 to 100 with higher scores indicating a greater impact of tinnitus on quality of life.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up Change from baseline to 3 months	-6.0 units on a scale Standard Deviation 15.8	-13.6 units on a scale Standard Deviation 18.4	-2.9 units on a scale Standard Deviation 13.6
Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up Change from baseline to 6 months	-10.3 units on a scale Standard Deviation 12.8	-11.0 units on a scale Standard Deviation 19.1	-5.3 units on a scale Standard Deviation 20.6
Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up Change from baseline to 12 months	-7.4 units on a scale Standard Deviation 16.3	-14.9 units on a scale Standard Deviation 17.2	-12.0 units on a scale Standard Deviation 15.5
Change in Tinnitus Handicap Inventory (THI) Score From Baseline to 3, 6, 12, and 18 Months Follow-up Change from baseline to 18 months	-6.1 units on a scale Standard Deviation 18.0	-12.6 units on a scale Standard Deviation 17.1	-9.4 units on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: Baseline to 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

10 point visual analog scale asking "How much of a problem is tinnitus?" on a scale from 0 "no problem at all" to 10 "as much as you can imagine"

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up Change from baseline to 6 months	-1.6 units on a scale Standard Deviation 2.4	-1.4 units on a scale Standard Deviation 2.3	-1.3 units on a scale Standard Deviation 2.6
Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up Change from baseline to 12 months	-1.9 units on a scale Standard Deviation 2.6	-2.0 units on a scale Standard Deviation 2.6	-2.1 units on a scale Standard Deviation 2.7
Change in Tinnitus Retraining Therapy Interview Visual Analogue Scales at 3, 6, 12, and 18 Months Follow-up Change from baseline to 18 months	-1.8 units on a scale Standard Deviation 3.0	-2.1 units on a scale Standard Deviation 2.4	-1.8 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Questionnaire emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 38 with higher scores representing greater emotional distress.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. Change from baseline to 3 months	-7.2 units on a scale Standard Deviation 6.3	-6.6 units on a scale Standard Deviation 8.0	-4.6 units on a scale Standard Deviation 6.2
Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. Change from baseline to 6 months	-8.8 units on a scale Standard Deviation 6.8	-7.8 units on a scale Standard Deviation 8.3	-6.0 units on a scale Standard Deviation 6.5
Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. Change from baseline to 12 months	-8.9 units on a scale Standard Deviation 6.4	-9.0 units on a scale Standard Deviation 7.0	-7.4 units on a scale Standard Deviation 5.8
Change in Tinnitus Questionnaire Emotional Distress Sub-scale Scores From Baseline to 3, 6, 12, and 18 Months. Change from baseline to 18 months	-8.1 units on a scale Standard Deviation 6.3	-8.7 units on a scale Standard Deviation 7.9	-7.4 units on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Questionnaire intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater intrusiveness of the tinnitus.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. Change from baseline to 3 months	-2.4 units on a scale Standard Deviation 3.3	-1.7 units on a scale Standard Deviation 2.8	-1.4 units on a scale Standard Deviation 2.5
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. Change from baseline to 6 months	-2.2 units on a scale Standard Deviation 2.7	-2.2 units on a scale Standard Deviation 3.1	-2.0 units on a scale Standard Deviation 3.2
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. Change from baseline to 12 months	-3.0 units on a scale Standard Deviation 3.0	-3.1 units on a scale Standard Deviation 3.0	-2.2 units on a scale Standard Deviation 3.3
Change in Tinnitus Questionnaire Intrusiveness Sub-scale Scores. Change from baseline to 18 months	-3.2 units on a scale Standard Deviation 3.3	-2.4 units on a scale Standard Deviation 2.9	-2.4 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including all data from participants with at least one follow-up visit

Change in Tinnitus Questionnaire auditory perceptual sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 14 with higher scores representing greater auditory difficulties.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. Change from baseline to 3 months	-2.5 units on a scale Standard Deviation 2.6	-1.8 units on a scale Standard Deviation 3.0	-1.2 units on a scale Standard Deviation 2.5
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. Change from baseline to 6 months	-2.4 units on a scale Standard Deviation 2.9	-2.4 units on a scale Standard Deviation 2.6	-2.1 units on a scale Standard Deviation 3.2
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. Change from baseline to 12 months	-2.6 units on a scale Standard Deviation 2.4	-2.3 units on a scale Standard Deviation 2.9	-2.6 units on a scale Standard Deviation 3.0
Change in Tinnitus Questionnaire Auditory Perceptual Difficulties Sub-scale Scores. Change from baseline to 18 months	-2.0 units on a scale Standard Deviation 3.0	-2.0 units on a scale Standard Deviation 3.2	-2.4 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Questionnaire sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater sleep disturbance.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. Change from baseline to 3 months	-1.4 units on a scale Standard Deviation 1.7	-1.9 units on a scale Standard Deviation 2.2	-1.2 units on a scale Standard Deviation 1.7
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. Change from baseline to 6 months	-1.7 units on a scale Standard Deviation 2.0	-1.8 units on a scale Standard Deviation 1.9	-1.2 units on a scale Standard Deviation 1.7
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. Change from baseline to 12 months	-1.7 units on a scale Standard Deviation 2.4	-2.3 units on a scale Standard Deviation 2.5	-1.4 units on a scale Standard Deviation 1.9
Change in Tinnitus Questionnaire Sleep Disturbance Sub-scale Scores. Change from baseline to 18 months	-1.6 units on a scale Standard Deviation 2.3	-2.2 units on a scale Standard Deviation 2.0	-1.2 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Questionnaire somatic complaint sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 8 with higher scores representing greater somatic complaints.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. Change from baseline to 3 months	-1.9 units on a scale Standard Deviation 2.0	-1.2 units on a scale Standard Deviation 1.9	-1.2 units on a scale Standard Deviation 2.1
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. Change from baseline to 6 months	-2.2 units on a scale Standard Deviation 1.7	-1.6 units on a scale Standard Deviation 1.8	-1.5 units on a scale Standard Deviation 2.0
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. Change from baseline to 12 months	-2.1 units on a scale Standard Deviation 1.8	-1.7 units on a scale Standard Deviation 2.0	-1.6 units on a scale Standard Deviation 2.0
Change in Tinnitus Questionnaire Somatic Complaint Sub-scale Scores. Change from baseline to 18 months	-1.7 units on a scale Standard Deviation 1.9	-1.5 units on a scale Standard Deviation 2.1	-1.3 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index intrusiveness sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater intrusiveness of the tinnitus.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. Change from baseline to 3 months	-1.9 units on a scale Standard Deviation 21.7	-6.3 units on a scale Standard Deviation 19.7	-2.9 units on a scale Standard Deviation 17.9
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. Change from baseline to 6 months	-11.9 units on a scale Standard Deviation 17.9	-8.8 units on a scale Standard Deviation 22.2	-10.4 units on a scale Standard Deviation 21.7
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. Change from baseline to 12 months	-8.1 units on a scale Standard Deviation 26.2	-16.6 units on a scale Standard Deviation 21.3	-19.4 units on a scale Standard Deviation 25.2
Change in Tinnitus Functional Index Intrusiveness Sub-scale Scores. Change from baseline to 18 months	-6.8 units on a scale Standard Deviation 27.8	-10.1 units on a scale Standard Deviation 20.6	-11.4 units on a scale Standard Deviation 26.4

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index reduced sense of control sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction of control.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. Change from baseline to 3 months	0.2 units on a scale Standard Deviation 19.0	-9.2 units on a scale Standard Deviation 23.6	-9.4 units on a scale Standard Deviation 17.0
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. Change from baseline to 6 months	-8.0 units on a scale Standard Deviation 18.5	-7.0 units on a scale Standard Deviation 24.9	-12.4 units on a scale Standard Deviation 22.1
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. Change from baseline to 12 months	-6.6 units on a scale Standard Deviation 20.1	-20.8 units on a scale Standard Deviation 25.1	-25.3 units on a scale Standard Deviation 24.7
Change in Tinnitus Functional Index Reduced Sense of Control Sub-scale Scores. Change from baseline to 18 months	-9.0 units on a scale Standard Deviation 21.5	-12.0 units on a scale Standard Deviation 24.0	-20.5 units on a scale Standard Deviation 27.6

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index cognitive interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater cognitive interference.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. Change from baseline to 3 months	-2.2 units on a scale Standard Deviation 20.0	-13.1 units on a scale Standard Deviation 22.5	-3.0 units on a scale Standard Deviation 21.2
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. Change from baseline to 6 months	-7.5 units on a scale Standard Deviation 17.3	-12.2 units on a scale Standard Deviation 23.3	-6.7 units on a scale Standard Deviation 22.4
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. Change from baseline to 12 months	-2.4 units on a scale Standard Deviation 21.4	-15.4 units on a scale Standard Deviation 21.4	-9.1 units on a scale Standard Deviation 24.5
Change in Tinnitus Functional Index Cognitive Interference Sub-scale Scores. Change from baseline to 18 months	-1.1 units on a scale Standard Deviation 22.2	-14.7 units on a scale Standard Deviation 21.2	-8.3 units on a scale Standard Deviation 29.2

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index sleep disturbance sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater sleep disturbance.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. Change from baseline to 3 months	-7.2 units on a scale Standard Deviation 23.9	-16.1 units on a scale Standard Deviation 24.9	-4.0 units on a scale Standard Deviation 21.1
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. Change from baseline to 6 months	-13.0 units on a scale Standard Deviation 27.3	-10.8 units on a scale Standard Deviation 28.4	-11.2 units on a scale Standard Deviation 23.5
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. Change from baseline to 12 months	-10.9 units on a scale Standard Deviation 27.7	-20.6 units on a scale Standard Deviation 26.9	-15.9 units on a scale Standard Deviation 29.0
Change in Tinnitus Functional Index Sleep Disturbance Sub-scale Scores. Change from baseline to 18 months	-11.1 units on a scale Standard Deviation 31.4	-20.2 units on a scale Standard Deviation 23.4	-10.0 units on a scale Standard Deviation 24.3

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index auditory difficulties sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater auditory difficulties.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. Change from baseline to 3 months	0.3 units on a scale Standard Deviation 26.0	-8.9 units on a scale Standard Deviation 24.5	1.2 units on a scale Standard Deviation 21.3
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. Change from baseline to 6 months	-5.3 units on a scale Standard Deviation 21.8	-3.8 units on a scale Standard Deviation 28.3	-2.5 units on a scale Standard Deviation 33.7
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. Change from baseline to 12 months	-7.9 units on a scale Standard Deviation 24.3	-13.2 units on a scale Standard Deviation 24.9	-11.8 units on a scale Standard Deviation 29.2
Change in Tinnitus Functional Index Auditory Difficulties Sub-scale Scores. Change from baseline to 18 months	-7.1 units on a scale Standard Deviation 21.1	-6.6 units on a scale Standard Deviation 22.3	-2.7 units on a scale Standard Deviation 29.2

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index relaxation interference sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater relaxation interference.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. Change from baseline to 3 months	-7.6 units on a scale Standard Deviation 24.3	-12.9 units on a scale Standard Deviation 26.7	-4.6 units on a scale Standard Deviation 24.8
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. Change from baseline to 6 months	-12.8 units on a scale Standard Deviation 18.5	-12.8 units on a scale Standard Deviation 27.8	-9.6 units on a scale Standard Deviation 24.9
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. Change from baseline to 12 months	-16.1 units on a scale Standard Deviation 23.5	-16.3 units on a scale Standard Deviation 28.1	-20.3 units on a scale Standard Deviation 33.5
Change in Tinnitus Functional Index Relaxation Interference Sub-scale Scores. Change from baseline to 18 months	-13.3 units on a scale Standard Deviation 26.7	-18.6 units on a scale Standard Deviation 30.2	-15.6 units on a scale Standard Deviation 33.1

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index emotional distress sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater emotional distress.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. Change from baseline to 3 months	-6.5 units on a scale Standard Deviation 18.7	-11.4 units on a scale Standard Deviation 22.1	-8.1 units on a scale Standard Deviation 16.7
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. Change from baseline to 6 months	-12.4 units on a scale Standard Deviation 25.6	-9.4 units on a scale Standard Deviation 19.8	-10.0 units on a scale Standard Deviation 26.1
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. Change from baseline to 12 months	-7.1 units on a scale Standard Deviation 25.0	-18.2 units on a scale Standard Deviation 22.1	-16.9 units on a scale Standard Deviation 22.7
Change in Tinnitus Functional Index Emotional Distress Sub-scale Scores. Change from baseline to 18 months	-7.5 units on a scale Standard Deviation 25.7	-15.9 units on a scale Standard Deviation 23.5	-8.8 units on a scale Standard Deviation 28.6

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Functional Index reduced quality of life sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 100 with higher scores representing greater reduction in quality of life.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. Change from baseline to 3 months	-4.6 units on a scale Standard Deviation 19.3	-12.0 units on a scale Standard Deviation 21.2	-4.6 units on a scale Standard Deviation 15.5
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. Change from baseline to 6 months	-7.0 units on a scale Standard Deviation 18.0	-10.7 units on a scale Standard Deviation 20.9	-7.6 units on a scale Standard Deviation 23.7
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. Change from baseline to 12 months	-3.7 units on a scale Standard Deviation 22.9	-16.8 units on a scale Standard Deviation 21.7	-12.8 units on a scale Standard Deviation 22.8
Change in Tinnitus Functional Index Reduced Quality of Life Sub-scale Scores. Change from baseline to 18 months	-0.3 units on a scale Standard Deviation 23.0	-16.6 units on a scale Standard Deviation 20.9	-6.4 units on a scale Standard Deviation 24.4

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Handicap Inventory functional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 44 with higher scores representing greater functional difficulties.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. Change from baseline to 3 months	-1.3 units on a scale Standard Deviation 7.9	-6.2 units on a scale Standard Deviation 8.7	0.5 units on a scale Standard Deviation 7.5
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. Change from baseline to 6 months	-3.2 units on a scale Standard Deviation 6.4	-4.1 units on a scale Standard Deviation 9.0	-1.2 units on a scale Standard Deviation 9.3
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. Change from baseline to 12 months	-2.2 units on a scale Standard Deviation 7.2	-6.6 units on a scale Standard Deviation 7.5	-4.0 units on a scale Standard Deviation 8.0
Change in Tinnitus Handicap Inventory Functional Sub-scale Scores. Change from baseline to 18 months	-1.5 units on a scale Standard Deviation 8.7	-5.1 units on a scale Standard Deviation 7.0	-2.4 units on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Handicap Inventory emotional sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 36 with higher scores representing greater emotional distress.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. Change from baseline to 3 months	-3.0 units on a scale Standard Deviation 6.7	-4.2 units on a scale Standard Deviation 6.9	-1.7 units on a scale Standard Deviation 5.4
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. Change from baseline to 6 months	-4.1 units on a scale Standard Deviation 5.9	-4.2 units on a scale Standard Deviation 7.3	-2.4 units on a scale Standard Deviation 8.5
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. Change from baseline to 12 months	-3.3 units on a scale Standard Deviation 7.1	-4.9 units on a scale Standard Deviation 6.3	-5.3 units on a scale Standard Deviation 6.3
Change in Tinnitus Handicap Inventory Emotional Sub-scale Scores. Change from baseline to 18 months	-2.8 units on a scale Standard Deviation 8.0	-4.4 units on a scale Standard Deviation 7.7	-4.3 units on a scale Standard Deviation 6.2

SECONDARY outcome

Timeframe: Baseline to 3, 6, 12, and 18 months follow-up

Population: Intention to treat, including data from all participants with at least one follow-up visit

Change in Tinnitus Handicap Inventory catastrophic sub-scale from baseline to follow-up. Sub-scale scores range from 0 to 20 with higher scores representing greater catastrophic effect of the tinnitus.

Outcome measures

Measure	Tinnitus Retraining Therapy (TRT) n=44 Participants TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=46 Participants Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=46 Participants The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. Change from baseline to 6 months	-3.0 units on a scale Standard Deviation 3.3	-2.7 units on a scale Standard Deviation 4.7	-1.8 units on a scale Standard Deviation 4.9
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. Change from baseline to 12 months	-1.9 units on a scale Standard Deviation 4.1	-3.5 units on a scale Standard Deviation 4.7	-2.7 units on a scale Standard Deviation 3.2
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. Change from baseline to 18 months	-1.7 units on a scale Standard Deviation 3.8	-3.2 units on a scale Standard Deviation 4.4	-2.7 units on a scale Standard Deviation 4.3
Change in Tinnitus Handicap Inventory Catastrophic Sub-scale Scores. Change from baseline to 3 months	-1.7 units on a scale Standard Deviation 3.6	-3.2 units on a scale Standard Deviation 4.8	-1.8 units on a scale Standard Deviation 3.4

Adverse Events

Tinnitus Retraining Therapy (TRT)

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Partial Tinnitus Retraining Therapy (Partial TRT)

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Standard of Care (SC)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tinnitus Retraining Therapy (TRT) n=51 participants at risk TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=51 participants at risk Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=49 participants at risk The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	0.00% 0/51 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	3.9% 2/51 • Number of events 2 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	0.00% 0/49 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.
Nervous system disorders Surgery	0.00% 0/51 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	2.0% 1/51 • Number of events 1 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	0.00% 0/49 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.

Other adverse events

Measure	Tinnitus Retraining Therapy (TRT) n=51 participants at risk TRT includes sound therapy using a conventional sound generator and educational directive counseling (DC). The conventional sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device generates low-level noise and is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Partial Tinnitus Retraining Therapy (Partial TRT) n=51 participants at risk Partial TRT includes treatment with a placebo sound generator (placebo SG) and directive counseling (DC). The placebo sound generator (SG) is a Tranquil model (General Hearing Instruments, Inc.), worn either inside- or outside-the-ear. The device is set at or just below the participant's mixing point (i.e., noise level that just blends with the tinnitus) and generates a low-level sound different from the active devices. Directive Counseling (DC) involves a one to two-hour educational session during which the participant is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, instruction on anatomy and physiology of hearing and tinnitus, introduction to the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and use of sound therapy and environmental sound in the habituation process.	Standard of Care (SC) n=49 participants at risk The standard of care arm includes care as typically delivered in US military medical centers The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
Psychiatric disorders Depression	17.6% 9/51 • Number of events 12 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	21.6% 11/51 • Number of events 21 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	18.4% 9/49 • Number of events 9 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.
Ear and labyrinth disorders Sudden hearing loss	0.00% 0/51 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	2.0% 1/51 • Number of events 1 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	0.00% 0/49 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.
Ear and labyrinth disorders Pain and swollen ear canal	2.0% 1/51 • Number of events 1 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	0.00% 0/51 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.	0.00% 0/49 • Adverse events were collected from baseline to the end of the 18 month follow-up period. The only adverse event systematically collected was depression, assessed as a score of 4 or more or endorsement of suicidal ideation on the Beck Depression Inventory Short Form. This instrument was administered at each study visit (baseline, 3, 6, 12, and 18 months follow-up). Other adverse events were not systematically collected, but reported at the time of incidence.

Additional Information

Roberta W. Scherer, Director Data Coordinating Center

Center for Clinical Trials and Evidence Synthesis, Johns Hopkins Bloomberg School of Public Health

Phone: 410 502 4636

Email: rschere1@jhu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place