Evaluation of Investigational Hearing Instrument Features
The goal of this clinical trial is to learn how hearing instruments perform in varying environmental settings in adults with hearing loss. The main questions it aims to answer are:
How do varying versions of hearing instrument features perform based on exposure to different environments? What is the hearing instrument user preference between varying versions of hearing instrument features?
Participants will be fit with hearing instruments in the lab, and asked to wear them for the duration of the study period in their home environment. Participants will be asked to answer questionnaires throughout the study period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Research Audiologist
- Phone Number: 800-679-4871
- Email: sv.clinical@sonova.com
Study Locations
-
-
Illinois
-
Aurora, Illinois, United States, 60504
- Phonak Audiology Research Center
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Contact:
- Study Coordinator
- Phone Number: 800-679-4871
- Email: sv.clinical@sonova.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult, age 18 - 95 years
- N4 hearing loss
- Experienced hearing aid user
- English fluency
- Cognitively able to complete complex listening tasks
Exclusion Criteria:
- Normal hearing, or hearing loss outside the specified range
- No hearing aid experience
- Unable to speak, read, or write English fluently
- Cognitive impairment
- Any other condition or situation that impacts eligibility to participate in or complete study tasks, at the discretion of the investigator
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hearing Aid Users
Participants will wear hearing instruments for the duration of the study period.
They will be asked to complete questionnaires about their environment and experience.
|
Conventional, daily wear hearing instruments will be used in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hearing instrument feature performance
Time Frame: From enrollment to the completion of data collection, approximately 6 weeks
|
Accuracy of hearing instrument feature performance based on environmental sampling and subjective reporting
|
From enrollment to the completion of data collection, approximately 6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SRF-26463
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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