Back to resultsIn Field Performance of a Hearing Aid Transducer
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receiver-in-canal hearing instrument
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate sensorineural hearing loss
- Adult
Exclusion Criteria:
- Inability or unwillingness to wear study devices for extended period of time.
Sites / Locations
- Phonak Audiology Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Receiver in the canal hearing instrument 3 month
Receiver in the canal hearing instrument 6 month
Arm Description
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months.
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months.
Outcomes
Primary Outcome Measures
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04787055
Brief Title
In Field Performance of a Hearing Aid Transducer
Official Title
A Study to Examine the Performance of a Hearing Aid Transducer During Typical, In-field Use
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.
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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Receiver in the canal hearing instrument 3 month
Arm Type
Experimental
Arm Description
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months.
Arm Title
Receiver in the canal hearing instrument 6 month
Arm Type
Experimental
Arm Description
Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months.
Intervention Type
Device
Intervention Name(s)
Receiver-in-canal hearing instrument
Intervention Description
Receiver-in-canal hearing instrument
Primary Outcome Measure Information:
Title
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Description
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time Frame
Three months after initial appointment
Title
Subjective Satisfaction of Hearing Aid Performance in Noisy Environments
Description
Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time Frame
Six months after initial appointment
Title
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Description
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time Frame
Three months after initial appointment
Title
Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media
Description
Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied.
Time Frame
Six months after initial appointment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate sensorineural hearing loss
Adult
Exclusion Criteria:
Inability or unwillingness to wear study devices for extended period of time.
Facility Information:
Facility Name
Phonak Audiology Research Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
12. IPD Sharing Statement
Learn more about this trial
In Field Performance of a Hearing Aid Transducer
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