Back to resultsEvaluation of Extended Wear Technology
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lyric extended wear hearing aid device A
Lyric extended wear hearing aid with fitting modification device B
Sponsored by
About this trial
This is an interventional other trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Mild, Moderate and Moderate Severe Hearing loss
- Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
Exclusion Criteria:
- Participants who can only wear a size XXS (extra-extra small) extended wear device
Sites / Locations
- Main Line Audiology Consultants
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
First Intervention
Arm Description
Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study)
Outcomes
Primary Outcome Measures
Subjective Questionnaire of Comfort
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Subjective Ratings of Occlusion With Both Devices
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04882800
Brief Title
Evaluation of Extended Wear Technology
Official Title
Evaluation of Fitting Modification for Extended Wear Technology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
June 15, 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
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.
Detailed Description
A interventional study in which participants will be fit with the commercially available device in one ear and the experimental device in the opposite ear. After two weeks, the devices will be switched so that the participant has worn each device in each ear for a total of 2 weeks. Participants will be blinded as to which device they are wearing in each ear. Comfort and sound quality will be assessed for each device prior to removing from ears.
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
Model Description
Participants will be fit with commercially available extended wear hearing aid device A in the right ear and extended wear hearing aid with fitting modifications device B in the left ear for two weeks (first intervention); then fit with extended wear hearing aid with fitting modifications device B in the right ear and commercially available extended wear hearing aid device A in left ear for two weeks (second intervention). There will be no washout period.
Masking
None (Open Label)
Masking Description
Participants will not know which device is in each ear, only that they are being fit with Lyric devices.
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Intervention
Arm Type
Experimental
Arm Description
Participants will be fit with currently available Lyric extended wear hearing aid device A in right ear and Lyric extended wear hearing aid with fitting modification device B in left ear for 14 days (Day 1 - Day 14 of study). They will then switch and be fit with Lyric extended wear hearing aid with fitting modification device B in the right ear and the commercially available Lyric device A in the left ear for 14 days (Day 15-Day 28 of study)
Intervention Type
Device
Intervention Name(s)
Lyric extended wear hearing aid device A
Intervention Description
Current commercially available extended wear hearing aid
Intervention Type
Device
Intervention Name(s)
Lyric extended wear hearing aid with fitting modification device B
Intervention Description
Extended wear hearing aid with fitting modifications
Primary Outcome Measure Information:
Title
Subjective Questionnaire of Comfort
Description
Subjective ratings of comfort of each device in the ear, on a scale from 0 (very comfortable) to 10 (very uncomfortable/painful). No statistical analysis was planned for this measure.
Time Frame
Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
Title
Subjective Ratings of Occlusion With Both Devices
Description
Subjective ratings on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Time Frame
Two weeks after fitting device A in right ear/device B in left ear (Day 14 of study), and two weeks after fitting device A in left ear/device B in right ear (Day 28 of study-final appointment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild, Moderate and Moderate Severe Hearing loss
Previous extended wear technology users who rejected or cancelled trials due to discomfort, feedback, migration, or poor sound quality due to fit issues
Exclusion Criteria:
Participants who can only wear a size XXS (extra-extra small) extended wear device
asymmetrical hearing loss
other diagnosis that may cause hearing fluctuation
inability to tolerate physical fit of Lyric devices
inability to be seen for four lab visits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Seitz-Paquette, AuD
Organizational Affiliation
Sonova AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main Line Audiology Consultants
City
Narberth
State/Province
Pennsylvania
ZIP/Postal Code
19072
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared
Learn more about this trial
Evaluation of Extended Wear Technology
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