AI Noise Reduction in Phonak Hearing Aids

February 4, 2026 updated by: Aniket Saoji, Mayo Clinic

Evaluation of Artificial Intelligence Based Noise Reduction in Phonak Hearing Aid on Patients With Hearing Impairment and Cochlear Implants

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Aniket A. Saoji

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hearing Aid only
Patients with hearing impairment who do not have a Cochlear implant

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.

Experimental: Cochlear Implant with Hearing Aid
Patients with hearing impairment who have a single-sided implant (using a hearing aid on the opposite ear)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single-word Testing
Time Frame: Baseline
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
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Aniket Saoji, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 16, 2024

First Posted (Actual)

December 19, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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