Trial Outcomes & Findings for Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids (NCT NCT03569228)

Last Updated: 2025-05-25

Results Overview

The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).

Recruitment status

TERMINATED

Study phase

Target enrollment

163 participants

Primary outcome timeframe

1 month

Results posted on

2025-05-25

Participant Flow

Participants were excluded from the study only if they failed pre-screening. In Study 2, participants were randomly assigned a sham audiogram. Participants in Study 2 were fit with 12 hearing aids and the "outcome" was deviation to target. Study 2 participants do not have the same pre-specified primary and secondary outcomes as those in Study 1 and 3 and not reported.

Participant milestones

Participant milestones
Measure	Study 1 (In-the-Ear) Group Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 2 (Open Fit Correction, Sham Audiogram 1) Sham Audiogram 1 represents a normal sloping to moderate sensorineural hearing loss. Please note: participants in this arm did not have this audiogram.	Study 2 (Open Fit Correction, Sham Audiogram 2) Sham Audiogram 2 represents a gradual normal sloping to moderate sensorineural hearing loss in participants. Please note: participants did not have this audiogram.	Study 2 (Open Fit Correction, Sham Audiogram 3) Sham Audiogram 3 represents a mild to severe sensorineural hearing loss. Please note: participants did not have this audiogram.	Study 3 (Open-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Overall Study STARTED	4	11	35	37	32	12	9	14	9
Overall Study COMPLETED	2	9	32	34	30	9	8	9	6
Overall Study NOT COMPLETED	2	2	3	3	2	3	1	5	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Study 1 (In-the-Ear) Group Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 2 (Open Fit Correction, Sham Audiogram 1) Sham Audiogram 1 represents a normal sloping to moderate sensorineural hearing loss. Please note: participants in this arm did not have this audiogram.	Study 2 (Open Fit Correction, Sham Audiogram 2) Sham Audiogram 2 represents a gradual normal sloping to moderate sensorineural hearing loss in participants. Please note: participants did not have this audiogram.	Study 2 (Open Fit Correction, Sham Audiogram 3) Sham Audiogram 3 represents a mild to severe sensorineural hearing loss. Please note: participants did not have this audiogram.	Study 3 (Open-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Overall Study Withdrawal by PI	0	0	2	2	1	0	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	0	1
Overall Study Screen Fail	2	2	1	1	1	3	1	5	2

Baseline Characteristics

Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 2 (Open-fit Corrections, Sham Audiogram 1) n=32 Participants Sham Audiogram 1 represents normal sloping to moderate sensorineural hearing loss.	Study 2 (Open-fit Corrections, Sham Audiogram 2) n=34 Participants Sham Audiogram 2 represents gradual normal sloping to moderate sensorineural hearing loss.	Study 2 (Open-fit Corrections, Sham Audiogram 3) n=30 Participants Sham Audiogram 3 represents mild sloping to severe sensorineural hearing loss.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=8 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Total n=139 Participants Total of all reporting groups
Age, Continuous	70.5 Years STANDARD_DEVIATION 6.4 • n=5 Participants	75.6 Years STANDARD_DEVIATION 4.4 • n=7 Participants	72.5 Years STANDARD_DEVIATION 6.8 • n=5 Participants	72.6 Years STANDARD_DEVIATION 6.9 • n=4 Participants	74.7 Years STANDARD_DEVIATION 5.0 • n=21 Participants	73.2 Years STANDARD_DEVIATION 6.6 • n=10 Participants	74.3 Years STANDARD_DEVIATION 4.6 • n=115 Participants	69.1 Years STANDARD_DEVIATION 10.5 • n=24 Participants	74.8 Years STANDARD_DEVIATION 4.8 • n=42 Participants	73.3 Years STANDARD_DEVIATION 6.5 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	9 Participants n=7 Participants	31 Participants n=5 Participants	33 Participants n=4 Participants	30 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	9 Participants n=24 Participants	6 Participants n=42 Participants	137 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	30 Participants n=21 Participants	8 Participants n=10 Participants	8 Participants n=115 Participants	9 Participants n=24 Participants	6 Participants n=42 Participants	138 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	3 Participants n=24 Participants	0 Participants n=42 Participants	10 Participants n=42 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	8 Participants n=7 Participants	31 Participants n=5 Participants	28 Participants n=4 Participants	28 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	6 Participants n=24 Participants	6 Participants n=42 Participants	125 Participants n=42 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Region of Enrollment United States	2 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants	34 Participants n=4 Participants	30 Participants n=21 Participants	9 Participants n=10 Participants	8 Participants n=115 Participants	9 Participants n=24 Participants	6 Participants n=42 Participants	139 Participants n=42 Participants

PRIMARY outcome

Timeframe: 1 month

Population: Only groups in Studies 1 and 3 are included. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=8 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Deviation From Target (in dB)	0 units on a scale (dB) Standard Deviation 0	2.85 units on a scale (dB) Standard Deviation 2.69	6.5 units on a scale (dB) Standard Deviation 6.7	6.6 units on a scale (dB) Standard Deviation 5.8	4.6 units on a scale (dB) Standard Deviation 4.9	3.5 units on a scale (dB) Standard Deviation 4.8

SECONDARY outcome

Timeframe: 1 month

Population: Only groups in Studies 1 and 3 are included. In the Study 3 closed-fit comparison group, 2 had missing APHAB outcomes. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose.

Abbreviate Profile of Hearing Aid Benefit (APHAB; Cox and Alexander, 1995). The APHAB contains 24 items that assess hearing problems across four subscales including: (1) ease of communication, (2) background noise, (3) reverberation, and (4) aversiveness to sounds. Items are answered using a 7-item response scale ranging from never (1%) to almost always (99%). Items typically are answered in unaided and aided conditions. Higher numbers indicated more problems. The difference in scores between the two conditions is a measure of benefit. For this study, however, the aided-aided version of the APHAB will be used. Study 1 and 3.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=6 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Abbreviate Profile of Hearing Aid Benefit	12.1 units on a 1 to 99 percent scale Standard Deviation 1.6	25.1 units on a 1 to 99 percent scale Standard Deviation 13.5	29.1 units on a 1 to 99 percent scale Standard Deviation 13.8	18.8 units on a 1 to 99 percent scale Standard Deviation 10.4	26.9 units on a 1 to 99 percent scale Standard Deviation 12.6	21.3 units on a 1 to 99 percent scale Standard Deviation 12.0

SECONDARY outcome

Timeframe: 1 month

Population: Only groups in Studies 1 and 3 are included. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose. Study 2 participants were not administered patient reported outcome measures nor did they undergo a field trial with hearing aids.

Client-Oriented Scale of Improvement (COSI; Dillon, James, \& Ginis, 1997). The listener nominates up to five listening goals on the COSI. After hearing-aid use, the listener assesses two outcomes for each goal. One outcome is the "degree of change" relative to the patient's unaided experience. Responses are recorded on a categorical scale from 'worse' to 'much better.' The second outcome is the final satisfactory "aided" ability for each goal as measured on a categorical scale from hardy ever (10%) to almost always (95%). The percentage of 'better' and 'much better' responses and the average of the final ability will be calculated across goals. Study 1 and 3.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=8 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Client-Oriented Scale of Improvement	61.7 percentage of final ability Standard Deviation 16.5	71.6 percentage of final ability Standard Deviation 19.3	71.8 percentage of final ability Standard Deviation 20.3	77.6 percentage of final ability Standard Deviation 18.5	72.7 percentage of final ability Standard Deviation 22.8	67.5 percentage of final ability Standard Deviation 22.0

SECONDARY outcome

Timeframe: 1 month

International Outcomes Inventory for Hearing Aids (IOI-HA; Cox et al., 2000). The IOI-HA consists of seven items including (1) use, (2) benefit, (3) satisfaction, (4) residual activity limitation, (5) residual participation restriction, (6) impact on others, and (7) quality of life. Each item has a unique 1-5 response scale. Scores range from 7-35 with higher scores indicating higher outcomes. Study 1 and 3.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=8 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
International Outcomes Inventory for Hearing Aids	31.0 units on a 1 to 5 scale, summed Standard Deviation 1.4	30.4 units on a 1 to 5 scale, summed Standard Deviation 3.0	30.9 units on a 1 to 5 scale, summed Standard Deviation 2.5	31.0 units on a 1 to 5 scale, summed Standard Deviation 4.0	28.8 units on a 1 to 5 scale, summed Standard Deviation 3.5	30.5 units on a 1 to 5 scale, summed Standard Deviation 2.6

SECONDARY outcome

Timeframe: 1 month

Population: In the Study 3 closed-fit comparison group, 2 had missing SADL outcomes. Study 2 did not include outcome measures as it was not a clinical trial. Study 2 was a one-session observational study required to develop corrections for Study 3.

Satisfaction with Amplification in Daily Life (SADL) (Cox and Alexander, 1999). The SADL questionnaire has 15 items that examine self-reported hearing-aid satisfaction. The following four subscales are included: (1) positive effect, (2) negative features, (3) personal image, and (4) service and cost. For the current study, item 14 on the service and cost subscale will not be used as the Veterans are not charged for the cost of their bilateral hearing aids. The SADL uses a 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item, which are averaged for each subscale and total scale score. Study 1 and 3.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=6 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Satisfaction With Amplification in Daily Life	6.1 units on a 1 to 7 scale Standard Deviation 0.5	6.1 units on a 1 to 7 scale Standard Deviation 0.4	5.8 units on a 1 to 7 scale Standard Deviation 0.8	6.5 units on a 1 to 7 scale Standard Deviation 0.2	6.0 units on a 1 to 7 scale Standard Deviation 0.5	6.3 units on a 1 to 7 scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 1 month

Population: Only groups in Studies 1 and 3 are included. In the Study 3 closed-fit comparison group, 2 had missing COSI outcomes. Study 2 is a single session observational study to determine correction factors for Study 3. Study 2 is not included for this purpose. Study 2 participants were not administered patient reported outcome measures nor did they undergo a field trial with hearing aids.

Degree of change (percentage of those goals that were categorized as 'better' or 'much better')

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=2 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=9 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=9 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) n=6 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) n=9 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) n=6 Participants Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Client Oriented Scale of Improvement (COSI)	25 percentage of 'better' or 'much better'	56.25 percentage of 'better' or 'much better'	62 percentage of 'better' or 'much better'	87.5 percentage of 'better' or 'much better'	51.8 percentage of 'better' or 'much better'	25 percentage of 'better' or 'much better'

OTHER_PRE_SPECIFIED outcome

Timeframe: Single session laboratory-based observational visit

Deviation from target (dB) averaged from 500 - 4000Hz across all 12 sham fittings. This is the sole outcome measure for Study 2 participants only. Study 1 and Study 3 participants do not have this outcome measure.

Outcome measures

Outcome measures
Measure	Study 1 (In-the-Ear) Group n=32 Participants Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - ITE hearing aids: Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 1 (Behind-the-Ear) Group n=34 Participants Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 1 - BTE hearing aids: Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Open-fit Comparison) n=30 Participants This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (open-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Closed-fit Comparison) This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Study 3 (closed-fit comparison): This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.	Study 3 (Experimental Open-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental open-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.	Study 3 (Experimental Closed-fit) Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Study 3 (experimental closed-fit): Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Deviation From Target for Open-Fit Corrections	0.95 dB Standard Deviation 2.21	1.98 dB Standard Deviation 3.52	4.54 dB Standard Deviation 3.21	—	—	—

Additional Information

Candice Quinn, Principal Investigator

Department of Veterans Affairs

Phone: 919-922-8046

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place