Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lyric Hearing Aid- Experimental Design
Lyric Hearing Aid- Commercially Available
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
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
Sites / Locations
- Sound Relief Hearing Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group A
Group B
Arm Description
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05274165
First Posted
March 1, 2022
Last Updated
June 9, 2023
Sponsor
Sonova AG
Collaborators
Sound Relief Hearing Center
1. Study Identification
Unique Protocol Identification Number
NCT05274165
Brief Title
Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
Official Title
Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Sound Relief Hearing Center
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In this study, new hearing aid candidates will be randomly assigned to one of two groups, but such that each group will have an equal number of participants.
Masking
Participant
Masking Description
Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
Arm Title
Group B
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Lyric Hearing Aid- Experimental Design
Intervention Description
Extended wear hearing aid with a fitting modification that is currently not available
Intervention Type
Device
Intervention Name(s)
Lyric Hearing Aid- Commercially Available
Intervention Description
Extended wear hearing aid that is currently available
Primary Outcome Measure Information:
Title
Trial to Success Rate
Description
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
Time Frame
Day 30 of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Sound Relief Hearing Center
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology
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