Evaluation of Extended Wear Hearing Aid for Mild Hearing Loss

NCT06746038 | Not Yet Recruiting FDA Device

• 1 other identifier: SRF-469
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensorineural Hearing Loss

Keywords

extended wear hearing aid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• AZBio Speech in noise testing

  Day 1 of 1 day study

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Interventions

Extended Wear Hearing Aid DEVICE

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.

Also known as: Lyric4

Experimental Group

Eligibility Criteria

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

You may qualify if:

• Meets requirements outlined on Lyric Candidacy Form
• Current Lyric hearing instrument user
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sonova AG: lead
• The Woodlands Hearing Center: collaborator

Study Sites (1)

The Woodlands Hearing Center

Shenandoah, Texas, 77384, United States

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Study Manager

CONTACT

630-821-5000; PARCResearch@phonak.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A single group of participants will be fit with the extended wear hearing devices and will be tested in both the aided and unaided conditions in various tasks. Conditions will be counterbalanced and all participants will experience the same conditions. Conditions will include unaided, aided with pre-calculation A, and aided with pre-calculation B.

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: January 15, 2025
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: December 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)