A Comparison of Hearing Aid Fitting Methods

Hearing Loss Clinical Trial

Official title:

A Comparison of Hearing Aid Fitting Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05376215
• Other study ID #: SRF-1236
• Status: Completed
• Phase: N/A
• Start date: August 17, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: August 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This investigation will compare hearing aid fitting methods between self-fitting and clinician fitting approaches by using a standardized questionnaire to evaluate subjective hearing aid benefit.

Description:

Participants will be fit with hearing aids using two different fitting methods (fitting A and fitting B). The order of the fitting will be randomized such that half of the participants will start out with fitting A and half of the participants will start out with fitting B. All participants will undergo baseline speech testing and answer a questionnaire about their experiences in daily life without hearing aids. All participants will use devices for a period of 1-2 weeks in their daily lives. After this first home trial, participants will return to the clinic where they will answer questionnaires regarding their experience with the devices. They will also perform aided speech testing. They will then be given devices with the second fitting method and will wear devices for a period of 1-2 weeks in their daily lives. Following the second home trial, all participants will return to the clinic to answer the same questionnaire that was given after home trial #1, and complete aided speech testing. The results for each of the two fitting methods will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 8, 2022
• Est. primary completion date: December 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Mild to moderate bilateral hearing loss

• First time (new) hearing aid users or experienced hearing aid users

• Ability to use a smartphone

• Fluent in English; ability to read and write in English

• Willing and able to provide informed consent

Exclusion Criteria:

• Self reported ear-related pathology including otorrhea within 90 days, dizziness, sudden onset or worsening of hearing loss within 90 days, visible deformity of the ear, otalgia

• Unilateral hearing loss

• Chronic, severe tinnitus

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abbreviated Profile of Hearing Aid Benefit (APHAB)	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.	Day 1 (unaided testing), Day 14(aided testing for first fitting method) and Day 28 (aided testing for second fitting method) of study
Secondary	Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss	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.	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