Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology

June 9, 2023 updated by: Sonova AG

Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Highlands Ranch, Colorado, United States, 80129
        • Sound Relief Hearing Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Device: Lyric Hearing Aid- Commercially Available
Extended wear hearing aid that is currently available
Experimental: Group B
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.
Device: Lyric Hearing Aid- Commercially Available
Extended wear hearing aid that is currently available
Device: Lyric Hearing Aid- Experimental Design
Extended wear hearing aid with a fitting modification that is currently not available

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trial to Success Rate
Time Frame: 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.
Day 30 of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonova AG

Collaborators

Sound Relief Hearing Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2022

Primary Completion (Actual)

September 9, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

March 1, 2022

First Submitted That Met QC Criteria

March 1, 2022

First Posted (Actual)

March 10, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 9, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRF-504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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