A Comparison of Hearing Aid Fitting Methods

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Experimental hearing aid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05376215

SRF-1236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Fitting method A first, then fitting method B

Active Comparator group

Description:

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.

Treatment:

Device: Experimental hearing aid

Fitting method B first, then fitting method A

Experimental group

Description:

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.

Treatment:

Device: Experimental hearing aid