Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss.

Study Overview

• Status: Not yet recruiting
• Conditions: Sensorineural Hearing Loss
• Intervention / Treatment: Device: Extended Wear Hearing Aid

Detailed Description

This study will assess the benefit of extended wear hearing aids for subjective listening effort, compared to the unaided condition, in adults with mild sensorineural hearing loss. Participants will be experienced hearing aid users who have previously worn or currently wear extended wear hearing devices. The primary objective will be to assess subjective listening effort, compared to unaided.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: 630-821-5000; Email: PARCResearch@phonak.com

Study Locations

• United States
  • Texas
    • Shenandoah, Texas, United States, 77384
      • The Woodlands Hearing Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Meets requirements outlined on Lyric Candidacy Form
• Current Lyric hearing instrument user
• 18 years of age or older at time of enrollment in the study
• Mild sensorineural hearing loss as defined by WHO, 4 frequency PTA of 20-34 dB HL, in the better hearing ear
• Good understanding (read/write/speak) of the English language
• Willingness to comply with all study requirements

Exclusion Criteria:

• Does not meet requirements outlined on Lyric Candidacy Form (see Chapter 9 of the TMF/ISF for SRF-469)
• Difficulty understanding/reading instructions when corrected for vision loss
• Impairments that would restrict participation in any of the evaluations
• Ear health conditions present at baseline that prevent immediate device replacement
• Conditions that would indicate the need for medical referral prior to hearing aid fitting, according to clinic's standard protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants who are fit with study Lyric devices and tested on speech intelligibility and effort using two different fitting algorithms	Device: Extended Wear Hearing Aid; Extended wear hearing aid means that the device is worn 24 hours per day, 7 days a week for months at a time. However, this study will only fit devices on participants for one testing session lasting 2 hours.; Other Names: Lyric4

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NASA Task Load Index (NASA-TLX)	A raw score on six demensions (mental demand, physical demand, temporal demand, frustration, effort, performance) on a scale from 1 (low/good) to 20 (high/poor). A higher score indicates higher levels of subjective effort.	Day 1 of 1 day study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AZBio Speech in noise testing	The percentage of words correctly repeated by the participant when listening to sentences played from a front speaker at a certain dB level, while background noise is presented simultaneously from four corner speakers. A higher percentage indicates better speech understanding in noise.	Day 1 of 1 day study

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: The Woodlands Hearing Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: extended wear hearing aid
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: SRF-469

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes