Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

Not Applicable

Completed

• Conditions: Hearing Loss
• Interventions: Device: Lyric Hearing Aid- Commercially Available; Device: Lyric Hearing Aid- Experimental Design

• Registration Number: NCT05274165
• Lead Sponsor: Sonova AG

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Study Start: 2022-03-29
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-30
• Results First Submitted: 2023-05-17
• Results First Submitted QC: 2023-05-17
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Results First Posted: 2023-06-12
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Lyric Hearing Aid- Commercially Available	Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Group B	Lyric Hearing Aid- Commercially Available	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.
Group B	Lyric Hearing Aid- Experimental Design	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.

Primary Outcome Measures

Name	Time	Method
Trial to Success Rate	Day 30 of study	Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.

Trial Locations

Locations (1)

Sound Relief Hearing Center; 🇺🇸 Highlands Ranch, Colorado, United States