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Evaluation of Extended Wear Technology

NCT ID: NCT04882800

Last Updated: 2022-12-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-08

Study Completion Date

2021-06-15

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.

Conditions

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Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Participants will not know which device is in each ear, only that they are being fit with Lyric devices.

Study Groups

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First Intervention

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)

Group Type EXPERIMENTAL

Lyric extended wear hearing aid device A

Intervention Type DEVICE

Current commercially available extended wear hearing aid

Lyric extended wear hearing aid with fitting modification device B

Intervention Type DEVICE

Extended wear hearing aid with fitting modifications

Interventions

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Lyric extended wear hearing aid device A

Current commercially available extended wear hearing aid

Intervention Type DEVICE

Lyric extended wear hearing aid with fitting modification device B

Extended wear hearing aid with fitting modifications

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonova AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Seitz-Paquette, AuD

Role: PRINCIPAL_INVESTIGATOR

Sonova AG

Locations

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Main Line Audiology Consultants

Narberth, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SRF-72

Identifier Type: -

Identifier Source: org_study_id