Evaluation of Extended Wear Technology

Hearing Loss Clinical Trial

Official title:

Evaluation of Fitting Modification for Extended Wear Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882800
• Other study ID #: SRF-72
• Status: Completed
• Phase: N/A
• Start date: April 8, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2022
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 15, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Lyric extended wear hearing aid device A
Current commercially available extended wear hearing aid
• Lyric extended wear hearing aid with fitting modification device B
Extended wear hearing aid with fitting modifications

Locations

Country	Name	City	State
United States	Main Line Audiology Consultants	Narberth	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sonova AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)