A Comparison of Hearing Aid Noise Programs on Speech Intelligibility

NCT06957730 | Completed FDA Device

• 1 other identifier: SRF-29404
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Hearing impaired participants will be fit with study devices which will have three different hearing aid programs. Speech intelligibility will be measured using validated tests for each of the three hearing aid programs. The order of the hearing aid programs will be randomized across participants and each participant will be blinded as to the programs being tested.

Conditions

Hearing Loss, Bilateral or Unilateral

Keywords

Hearing Loss

Outcome Measures

Primary Outcomes (1)

• AZBio Speech in noise testing

  A list of 20 sentences is presented from a speaker located in front of the participant. At the same time, background noise is presented from the same speaker at various SNR (Signal to Noise Ratio) levels. That is, speech may be presented 5 dB lower/softer than the noise up to 5 dB higher/louder than the noise. The number of words correct is counted and a percentage from the total number of words presented is calculated. A higher percentage is better and indicates better speech intelligibility. This test will be conducted for all three hearing aid program settings.

  Day 1 of 1 day study

Secondary Outcomes (1)

• Subjective ratings of sound quality

  Day 1 of 1 day study

Study Arms (1)

Phonak Audeo RIC

EXPERIMENTAL

All participants are fit with the Audeo RIC hearing aids, which are programmed with three different settings. All participants are tested with all three settings.

Device: Phonak Audeo Infinio Hearing Aid

Interventions

Phonak Audeo Infinio Hearing Aid DEVICE

Commercially available receiver-in-canal (RIC) style hearing aid manufactured by Sonova.

Phonak Audeo RIC

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral moderate to severe hearing loss (N3-N4)
• Experienced hearing aid user
• Fluent in English
• Cognitively able to complete complex listening tasks

You may not qualify if:

• Unilateral hearing loss
• New hearing aid user
• Unable or unwilling to complete complex listening tasks

Sponsors & Collaborators

• Sonova AG: lead

Study Sites (1)

Phonak Audiology Research Center

Aurora, Illinois, 60504, 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

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: All participants will be tested with the same three hearing aid programs, but the order of the programs will be randomized for each participant.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 4, 2025
• Study Start: April 22, 2025
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)