Evaluation of Extended Wear Technology

Sonova

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Lyric extended wear hearing aid device A; Device: Lyric extended wear hearing aid with fitting modification device B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04882800

SRF-72

Details and patient eligibility

About

Evaluating the efficacy and effectiveness of an advancement in the fitting characteristics of extended wear technology with the commercially available device as a comparator.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

First Intervention

Experimental group

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)

Treatment:

Device: Lyric extended wear hearing aid device A

Device: Lyric extended wear hearing aid with fitting modification device B