Recruiting

AI Noise Reduction

Sponsor:

Mayo Clinic

Code:

NCT06743295

Conditions

Hearing Loss

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06743295

Start date

Apr 24, 2025

Status verified date

Feb, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hearing Aid only

Patients with hearing impairment who do not have a Cochlear implant

experimental: Cochlear Implant with Hearing Aid

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

Interventions

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

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.

Primary outcome measure

  • Single-word Testing [ Time Frame: Baseline ]
  • Sentence Testing [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Clinical Research Study Coordinator

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Research Study Coordinator

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

Principal Investigator:

Aniket A. Saoji

More Information

Sponsor

Mayo Clinic

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • hearing aid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-02-06.