AI Noise Reduction in Phonak Hearing Aids

NCT06743295 | Recruiting FDA Device

• 1 other identifier: 24-009408
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for hearing impaired patients.

Conditions

Hearing Loss

Keywords

hearing aid

Outcome Measures

Primary Outcomes (2)

• Single-word Testing

  Participants will listen to a list of 50 words and repeat each word aloud. Results are reported as a percentage of correctly repeated words out of 50.

  Baseline

• Sentence Testing

  Participants will listen to a list of 20 sentences and repeat each sentence aloud. Results are reported as a percentage of correctly repeated sentences out of 20.

  Baseline

Study Arms (2)

Hearing Aid only

EXPERIMENTAL

Patients with hearing impairment who do not have a Cochlear implant

Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction

Cochlear Implant with Hearing Aid

EXPERIMENTAL

Patients with hearing impairment who have a single-sided implant (using a hearing aid on the opposite ear)

Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction

Interventions

DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction DEVICE

Participants with hearing loss will be fitted with the Phonak Audéo Sphere™ Infinio (PAI) hearing aid with artificial intelligence (AI)-based noise reduction, which incorporates deep neural networks (DNN) technology to reduce background noise. Speech stimuli, presented at a comfortable level of approximately 60 dB SPL (like normal conversation), will be delivered via a loudspeaker positioned directly in front of the participant. They will be tested in 3 listening environments: quiet, moderate noise, high noise. Speech perception scores will be measured as a function of each hearing aid program setting: quiet setting, moderate noise, and advanced AI-based reduction for high noise.

Cochlear Implant with Hearing Aid; Hearing Aid only

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with hearing impairment not using hearing aids
• Individuals with hearing impairment currently using hearing aids
• Cochlear implant patients with a single-sided implant (using a hearing aid in the opposite ear)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

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 Officials

• Aniket Saoji, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Study Coordinator

CONTACT

507-293-2445; tombers.nicole@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Otolaryngology

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: April 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)