Evaluation of Extended Wear Technology

NCT04882800 | Completed Results FDA Device

• 1 other identifier: SRF-72
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

First Intervention

EXPERIMENTAL

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

Interventions

Lyric extended wear hearing aid device A DEVICE

Current commercially available extended wear hearing aid

First Intervention

Lyric extended wear hearing aid with fitting modification device B DEVICE

Extended wear hearing aid with fitting modifications

First Intervention

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Main Line Audiology Consultants

Narberth, Pennsylvania, 19072, United States

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: Sonova US

phonakaudiologyresearch@gmail.com

630-821-5000

Study Officials

• Kevin Seitz-Paquette, AuD

  Sonova AG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will not know which device is in each ear, only that they are being fit with Lyric devices.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 12, 2021
• Study Start: April 8, 2021
• Primary Completion: May 31, 2021
• Study Completion: June 15, 2021
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)