Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Lyric Hearing Aid- Commercially Available; Device: Lyric Hearing Aid- Experimental Design

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05274165

SRF-504

Details and patient eligibility

About

Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.

After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.

Full description

Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mild to moderate hearing loss
• New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
• Must meet Lyric candidacy (see exclusion criteria)

Exclusion criteria

• middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
• radiation therapy to head or neck area
• participants who need regular MRI testing
• participants who regularly scuba dive or swim underwater

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Group A

Active Comparator group

Description:

Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.

Treatment:

Device: Lyric Hearing Aid- Commercially Available

Group B

Experimental group

Description:

Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.

Treatment:

Device: Lyric Hearing Aid- Commercially Available

Device: Lyric Hearing Aid- Experimental Design