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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05274165
Other study ID # SRF-504
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2022
Est. completion date September 30, 2022

Study information

Verified date June 2023
Source Sonova AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 30, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Lyric Hearing Aid- Experimental Design
Extended wear hearing aid with a fitting modification that is currently not available
Lyric Hearing Aid- Commercially Available
Extended wear hearing aid that is currently available

Locations

Country Name City State
United States Sound Relief Hearing Center Highlands Ranch Colorado

Sponsors (2)

Lead Sponsor Collaborator
Sonova AG Sound Relief Hearing Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trial to Success Rate Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure. Day 30 of study
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