Trial Outcomes & Findings for Feasibility and Acceptability of Using Low-Gain Hearing Aids for Bothersome Tinnitus (NCT NCT03904264)

Last Updated: 2023-11-21

Results Overview

The Tinnitus Functional Index (TFI) is a statistically validated measure of the functional impact of tinnitus. The TFI was developed to be sensitive to changes in function as a result of intervention for tinnitus. Range is 0 - 100, higher numbers indicates greater level of distress and functional impact.

Recruitment status

COMPLETED

Study phase

Target enrollment

65 participants

Primary outcome timeframe

The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline

Results posted on

2023-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Hearing Aid Study Measure the reduction in tinnitus handicap when mild amplification through receiver-in-the-canal hearing aids is provided to adults with bothersome tinnitus and normal hearing thresholds. Receiver in the canal (RIC) hearing aids: The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.	VA Clinician Interviews Document the opinions, procedures, and rationale used clinically to make decisions regarding fitting mild amplification for tinnitus on Veterans with bothersome tinnitus and normal hearing thresholds. The data for this arm of the study will be collected via telephone interview.
Overall Study STARTED	11	54
Overall Study COMPLETED	3	17
Overall Study NOT COMPLETED	8	37

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data was not collected for the interviews

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hearing Aid Study n=11 Participants Measure the reduction in tinnitus handicap when mild amplification through receiver-in-the-canal hearing aids is provided to adults with bothersome tinnitus and normal hearing thresholds. Receiver in the canal (RIC) hearing aids: The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.	VA Clinician Interviews n=54 Participants Document the opinions, procedures, and rationale used clinically to make decisions regarding fitting mild amplification for tinnitus on Veterans with bothersome tinnitus and normal hearing thresholds. The data for this arm of the study will be collected via telephone interview.	Total n=65 Participants Total of all reporting groups
Age, Continuous	41.45 Years STANDARD_DEVIATION 8.69 • n=11 Participants • Data was not collected for the interviews	—	41.45 Years STANDARD_DEVIATION 8.69 • n=11 Participants • Data was not collected for the interviews
Sex: Female, Male Female	2 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	2 Participants n=11 Participants • Data was not collected for interviews
Sex: Female, Male Male	9 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	9 Participants n=11 Participants • Data was not collected for interviews
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	11 Participants n=11 Participants • Data was not collected for interviews
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) Asian	1 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	1 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) Black or African American	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) White	9 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	9 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) More than one race	1 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	1 Participants n=11 Participants • Data was not collected for interviews
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=11 Participants • Data was not collected for interviews	0 Participants Data was not collected for interviews	0 Participants n=11 Participants • Data was not collected for interviews
Region of Enrollment United States	11 Participants n=11 Participants	54 Participants n=54 Participants	65 Participants n=65 Participants

PRIMARY outcome

Timeframe: The Tinnitus Functional index will be administered at baseline, 2-3 weeks after baseline, and 3 months after baseline

Population: TFI was not administered for VA Clinician Interviews

Outcome measures

Outcome measures
Measure	Hearing Aid Study n=11 Participants Measure the reduction in tinnitus handicap when mild amplification through receiver-in-the-canal hearing aids is provided to adults with bothersome tinnitus and normal hearing thresholds. Receiver in the canal (RIC) hearing aids: The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.
Tinnitus Functional Index Change Baseline	53.31 units on a scale Standard Deviation 22.68
Tinnitus Functional Index Change 2-3 weeks	44.10 units on a scale Standard Deviation 23.02
Tinnitus Functional Index Change 3 months	64.93 units on a scale Standard Deviation 25.25

Adverse Events

Hearing Aid Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

VA Clinician Interviews

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tara Zaugg, AuD / CRH REC Consultant, VISN 20 and REC ICC Clinical Lead, VISN 20

Department of Veterans Affairs

Phone: 208-422-1000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place