Evaluation of Extended Wear Technology

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Fitting Modification for Extended Wear Technology

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Lyric extended wear hearing aid device A
* Device: Lyric extended wear hearing aid with fitting modification device B


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First Intervention<br>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) | Device: Lyric extended wear hearing aid device A<br>* Current commercially available extended wear hearing aid<br>Device: Lyric extended wear hearing aid with fitting modification device B<br>* Extended wear hearing aid with fitting modifications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 
| 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) | 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) |