- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06743295
AI Noise Reduction in Phonak Hearing Aids
Evaluation of Artificial Intelligence Based Noise Reduction in Phonak Hearing Aid on Patients With Hearing Impairment and Cochlear Implants
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Clinical Research Study Coordinator
- Phone Number: 507-293-2445
- Email: tombers.nicole@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Research Study Coordinator
- Phone Number: 507-293-2445
- Email: tombers.nicole@mayo.edu
-
Principal Investigator:
- Aniket A. Saoji
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Investigators
- Principal Investigator: Aniket Saoji, PhD, Mayo Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-009408
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Hearing Loss
-
MED-EL Elektromedizinische Geräte GesmbHCompletedHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Unilateral | Hearing Loss, MixedAustria, Germany, United Kingdom
-
Oticon MedicalCompletedEar Diseases | Hearing Loss, Conductive | Hearing Loss Mixed | Hearing Disability | Conductive Hearing Loss | Conductive Hearing Loss, Bilateral | Conductive Hearing Loss, UnilateralUnited Kingdom
-
Oticon MedicalNot yet recruitingSensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound
-
Manchester University NHS Foundation TrustUniversity of ManchesterCompletedCochlear Hearing Loss | Sensorineural Hearing Loss, BilateralUnited Kingdom
-
Truway Health, Inc.Enrolling by invitationSensorineural Hearing Loss | Tinnitus | Sudden Hearing Loss | Acoustic Trauma | Inner Ear Injury | Noise-Induced Hearing Loss | Vestibular DysfunctionUnited States
-
University of California, San FranciscoPatient-Centered Outcomes Research InstituteRecruitingHearing Loss | Hearing Loss, Sensorineural | Hearing Loss, Bilateral | Hearing Loss, Conductive | Hearing Loss, Noise-Induced | Hearing Loss, Unilateral | Hearing Loss, Mixed | Hearing Disorders in ChildrenUnited States
-
Envoy Medical CorporationActive, not recruitingSensorineural Hearing Loss | Sensorineural Hearing Loss (Disorder) | Sensorineural Hearing Loss, Bilateral | Sensorineural Hearing Loss, Severe | Sensorineural Hearing Loss, Profound | Sensori-Neural DeafnessUnited States
-
Oticon MedicalCompletedConductive Hearing Loss | Conductive and Sensori-neural Hearing Loss in the Same Ear | Unilateral, Profound Sensori-neural Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Presbycusis | Noise Induced Hearing Loss | Sudden Hearing LossUnited States
-
Frequency TherapeuticsCompletedHearing Loss, Sensorineural | Noise Induced Hearing Loss | Sudden Hearing LossUnited States