A Comparison of Hearing Aid Fitting Methods

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Experimental hearing aid

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2022
• Primary Completion (Actual): December 8, 2022
• Study Completion (Actual): December 8, 2022

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-1236

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes