A Comparison of Hearing Aid Fitting Methods

NCT05376215 | Completed Results FDA Device

• 1 other identifier: SRF-1236
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Speech Perception in Noise, Expressed in Decibel (dB) Signal to Noise Ratio (SNR) Loss

  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

Study Arms (2)

Fitting method A first, then fitting method B

ACTIVE COMPARATOR

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

Fitting method B first, then fitting method A

EXPERIMENTAL

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

Interventions

Experimental hearing aid DEVICE

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 A first, then fitting method B; Fitting method B first, then fitting method A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• University of South Florida: collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33620, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Research
• Organization: Phonak Audiology Research Center

phonakaudiologyresearch@gmail.com

630-821-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be fit with two sets of identical devices. One set will be programmed to fitting method A and one set will be programmed to fitting method B. Subjects will be blinded as to which set they are sent on a home trial with. Outcomes will be assessed at return visits by a second sub-investigator who does not know which devices the subject is wearing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is a prospective, repeated measures, within-subject, cross over design. Subjects will be assigned in random order to the two fitting methods. Subjects will be blinded as to which fitting method they are using during the home trials.

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: May 17, 2022
• Study Start: August 17, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: September 1, 2023
• Results First Posted: September 1, 2023

Record last verified: 2023-08

Locations

US (1)