Trial Outcomes & Findings for A Comparison of Hearing Aid Fitting Methods (NCT NCT05376215)

Results Overview

A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose "Always" to the statement "When I am having a quiet conversation with a friend, I have difficulty understanding". The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study

Results posted on

2023-09-01

Participant Flow

After the initial appointment in which participants were fit with both fitting methods, there was a wash out period of 1-5 days. After the wash-out period, participants returned to the site at which time they were assigned/randomized into an arm of the study. This wash-out period provided time to reduce the possibility that participants would remember how each fitting method sounded to them, and therefore reduce the chance for bias.

Participant milestones

Participant milestones
Measure	Fitting Method A First, Then Fitting Method B Participants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.	Fitting Method B First, Then Fitting Method A Participants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
Overall Study STARTED	23	21
Overall Study Completed First Assigned Fitting Method	22	20
Overall Study Completed Second Fitting Method	21	19
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fitting Method A First, Then Fitting Method B Participants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.	Fitting Method B First, Then Fitting Method A Participants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
Overall Study Withdrawal by Subject	2	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fitting Method A First, Then Fitting Method B n=23 Participants Participants will be fit with a set of hearing devices that are programmed to fitting method A first. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Following a home trial with fitting method A, participants will then be fit with a set of hearing devices that are programmed to fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.	Fitting Method B First, Then Fitting Method A n=21 Participants Participants will be fit with a set of hearing aids that are programmed using fitting method B. This fitting method will use a different set of programming parameters and software to determine the most appropriate algorithm. Following a home trial with fitting method B, participants will then be fit with a set of hearing devices that are programmed to fitting method A. This fitting method will use specific programming parameters and software to determine the most appropriate fitting algorithm. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.	Total n=44 Participants Total of all reporting groups
Age, Continuous	68 years STANDARD_DEVIATION 11.68 • n=23 Participants	68 years STANDARD_DEVIATION 7.94 • n=21 Participants	68 years STANDARD_DEVIATION 9.96 • n=44 Participants
Sex: Female, Male Female	9 Participants n=23 Participants	10 Participants n=21 Participants	19 Participants n=44 Participants
Sex: Female, Male Male	14 Participants n=23 Participants	11 Participants n=21 Participants	25 Participants n=44 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study

A validated questionnaire that assesses the subjective benefit of hearing aids in daily life. Participants rate their difficulty hearing in different situations, going from Always (99%), Almost Always (87%), Generally (75%), Half the time (50%), Occasionally (25%), Seldom (12%) or Never (1%). For example, the participant may choose "Always" to the statement "When I am having a quiet conversation with a friend, I have difficulty understanding". The questions are categorized into 4 different sub-scales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness. The global score is calculated by taking the average of three of the subscales: EC, BN, and RV. The scores can range from 1% to 99%. Global Benefit is calculated by subtracting the aided global score from the unaided global score. The mean global benefit is calculated for each fitting method, and a higher benefit score is better. Result reported is the global benefit score for each fitting method.

Outcome measures

Outcome measures
Measure	Fitting Method A n=41 Participants All participants who completed a home trial with devices using fitting method A.	Fitting Method B n=41 Participants All participants who completed a home trial with devices using fitting method B.
Abbreviated Profile of Hearing Aid Benefit (APHAB)	0.099 score on a scale Standard Deviation 0.1695	0.106 score on a scale Standard Deviation 0.1309

SECONDARY outcome

Timeframe: Day 1 (unaided/baseline testing) of study, day 14 (aided testing with first fitting method) and day 28 (aided testing with second fitting method) of study

Population: All participants who completed unaided/baseline speech in noise testing and aided speech in noise testing with both fitting methods so that the aided benefit score could be calculated.

Objective speech in noise testing calculates the level in which speech stimuli needs to be louder than background noise for the participant to correctly repeat back 50% of key words. A lower score/dB level is better. For example, a score of 2 dB means that the speech needs to be louder than the background noise by 2 dB in order for the individual to correctly repeat 50% of the words. However, a score of 10 dB means that the speech needs to be 10 dB louder than the background noise for the individual to correctly repeat 50% of the words. This test is done in the unaided condition, as well as with both aided conditions (fitting method A and fitting method B) and the benefit score for each fitting method is determined by subtracting the aided dB SNR score from the unaided dB SNR score. A higher benefit score is better.

Outcome measures

Outcome measures
Measure	Fitting Method A n=40 Participants All participants who completed a home trial with devices using fitting method A.	Fitting Method B n=40 Participants All participants who completed a home trial with devices using fitting method B.
Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss	-0.131 decibels (dB) Standard Deviation 1.81	-0.069 decibels (dB) Standard Deviation 1.54

Adverse Events

Fitting Method A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fitting Method B

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fitting Method A n=41 participants at risk All enrolled participants who completed a two week home trial with Fitting Method A. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.	Fitting Method B n=41 participants at risk All enrolled participants who completed a two week home trial with Fitting Method B. Experimental hearing aid: This hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and by use with a mobile application.
Ear and labyrinth disorders ear canal occlusion	0.00% 0/41 • Four weeks	2.4% 1/41 • Number of events 1 • Four weeks

Additional Information

Director of Research

Phonak Audiology Research Center

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Prior to any publication or presentation, Sonova reserves the right to review, oppose, or restrict the publication or presentation of protected intellectual property and/or confidential information. If an objection is raised by Sonova, discussion shall be held without delay to determine acceptable modifications to resolve the issue and allow dissemination within sixty days.
Publication restrictions are in place

Restriction type: OTHER