Evaluation of Extended Wear Technology

Not Applicable

Completed

• Conditions: Hearing Loss

• Registration Number: NCT04882800
• Lead Sponsor: Sonova AG

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.

Study Timeline

• Study Start: 2021-04-08
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-11
• Study First Posted: 2021-05-12
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-15
• Disposition First Submitted: 2022-05-31
• Status Verified: 2022-07
• Results First Submitted: 2022-08-03
• Results First Submitted QC: 2022-11-16
• Disposition First Submitted QC: 2022-11-16
• Last Update Submitted: 2022-11-16
• Results First Posted: 2022-12-14
• Disposition First Posted: 2022-12-14
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Subjective Ratings of Occlusion With Both Devices	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 on how plugged participants' ears felt with each device in ear,on scale from 0 (not at all) to 10 (extremely plugged/cannot tolerate)
Subjective Questionnaire of Comfort	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 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.

Trial Locations

Locations (1)

Main Line Audiology Consultants; 🇺🇸 Narberth, Pennsylvania, United States