Investigating Hearing Aid Frequency Response Curves

Sonova

Status: Completed

Conditions: Hearing Loss, Bilateral; Hearing Loss, Sensorineural

Treatments: Device: Hearing Aid - Variation #2; Device: Hearing Aid - Variation #1; Device: Hearing Aid - Variation #4; Device: Hearing Aid - Variation #3; Device: Hearing Aid - Standard Curve

Study type: Interventional

Funder types: Industry

Identifiers

NCT05521308

SRF-3167

Details and patient eligibility

About

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

Full description

Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

Enrollment: 33 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• N2 - N4 Hearing losses
• Health Outer ear
• no visible congenital or traumatic deformity of the outer ear
• Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
• Ability to answer questions and repeat sentences
• No history of problematic tinnitus or pain/discomfort from loud sounds
• No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature
• Willingness to wear different styles of couplings
• Willingness to wear binaural fitting
• Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
• Ability to travel throughout facility

Exclusion criteria

• Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
• Limited mobility/not able to come to the scheduled visit
• Inability to produce reliable hearing test results
• History of active drainage from the ear in the previous 90 days
• Abnormal appearance of the eardrum and ear canal.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Participants with Hearing Loss

Experimental group

Description:

Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.

Treatment:

Device: Hearing Aid - Standard Curve

Device: Hearing Aid - Variation #3

Device: Hearing Aid - Variation #4

Device: Hearing Aid - Variation #1

Device: Hearing Aid - Variation #2