Hearing LossNCT06743295
AI Noise Reduction in Phonak Hearing Aids
A study testing DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction in people with Hearing Loss, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Clinical Research Study Coordinator, 507-293-2445, tombers.nicole@mayo.edu
Aniket A. Saoji
About this study
Official title: 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.
- Conditions
- Hearing Loss
- Being tested
- DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction
- Keywords
- hearing aid
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reductionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid only | Experimental | Patients with hearing impairment who do not have a Cochlear implant Receives: 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) Receives: Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start24 Apr 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aniket Saoji, Mayo Clinic
- Investigators
- Aniket Saoji, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743295
- Sponsor's protocol ID
- 24-009408
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Artificial Intelligence Based Noise Reduction in Phonak Hearing Aid on Patients With Hearing Impairment and Cochlear Implants
- ClinicalTrials.gov ID
- NCT06743295
- Acronym / sponsor ID
- 24-009408
- Conditions
- Hearing Loss
- Keywords
- hearing aid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid only | Experimental | Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reductionPatients with hearing impairment who do not have a Cochlear implant |
| Cochlear Implant with Hearing Aid | Experimental | Device: DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reductionPatients with hearing impairment who have a single-sided implant (using a hearing aid on the opposite ear) |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reductionParticipants 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. | Device | Cochlear Implant with Hearing Aid, Hearing Aid only |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aniket Saoji, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip Artificial intelligence-based noise reduction in people with Hearing Loss, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Study Coordinator (507-293-2445, tombers.nicole@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single-word Testing (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.