AI Noise Reduction for Hearing Loss

Overseen By Clinical Research Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: None

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4-6 weeks

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip can help people with hearing loss understand speech better by reducing background noise. The researchers aim to determine if this technology can improve hearing for those using hearing aids or cochlear implants. Suitable participants include individuals who have difficulty hearing and use either only hearing aids or one cochlear implant with a hearing aid in the other ear. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance hearing technology for many.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip is safe for hearing impaired patients?

Research has shown that the DEEPSONIC™ chip is reliable and provides clear sound. It improves speech clarity by instantly separating voices from background noise. Users generally find it comfortable, and studies have reported no major safety issues.

Although specific data on side effects is unavailable, the chip's use in other hearing aids suggests safety. Popular hearing aid brands already use the AI technology in DEEPSONIC™, further supporting its safety for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip because it represents a significant leap forward in hearing technology. Unlike traditional hearing aids and cochlear implants that primarily amplify sound, DEEPSONIC™ uses advanced AI to actively reduce background noise, enhancing speech clarity in noisy environments. This neural integration chip is designed to work seamlessly with both hearing aids and cochlear implants, offering a more tailored and effective hearing experience. By focusing on sound optimization rather than mere amplification, DEEPSONIC™ has the potential to significantly improve quality of life for those with hearing impairments.

What evidence suggests that the DEEPSONIC™ AI chip is effective for hearing loss?

Studies have shown that the DEEPSONIC™ chip can significantly enhance speech comprehension, particularly in noisy environments. It employs AI to isolate voices from background noise, helping users concentrate on conversations. Research indicates that this technology processes sound faster and more accurately than other hearing aids. Previous users reported clearer and more natural sound experiences. In this trial, participants will use either a hearing aid alone or a cochlear implant with a hearing aid, both featuring the DEEPSONIC™ chip, to assess its effectiveness in improving hearing for various user groups. ^{1 6 7 8 9}

Who Is on the Research Team?

Aniket Saoji, PhD AuD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with hearing impairment, whether they are new to using hearing aids or currently use them. It also includes those who have a cochlear implant in one ear and use a hearing aid in the other. People already satisfied with their current hearing aids or unable to follow the study protocol may not qualify.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Participants undergo baseline testing including single-word and sentence testing to assess hearing and speech perception

1 week

1 visit (in-person)

Treatment

Participants use the Phonak hearing aid with AI-based noise reduction to evaluate improvement in hearing and speech perception

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip

Trial Overview The trial is testing DEEPSONIC™, an AI-based noise reduction technology integrated into Phonak Hearing Aids. The goal is to see if this advanced feature can improve speech understanding and overall hearing in noisy environments compared to standard models.

How Is the Trial Designed?

Group I: Hearing Aid only Experimental Treatment 1 Intervention

Patients with hearing impairment who do not have a Cochlear implant

Group II: Cochlear Implant with Hearing Aid Experimental Treatment 1 Intervention

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

DEEPSONIC™ Deep Sound Optimized Neural Integrated Chip is already approved in European Union, United States, Canada, Switzerland for the following indications:

Approved in European Union as DEEPSONIC AI chip for:

• Hearing impairment
• Speech perception improvement

Approved in United States as DEEPSONIC AI chip for:

• Hearing impairment
• Speech perception improvement

Approved in Canada as DEEPSONIC AI chip for:

• Hearing impairment
• Speech perception improvement

Approved in Switzerland as DEEPSONIC AI chip for:

• Hearing impairment
• Speech perception improvement

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A new ear modeling method using acoustic filter theory was developed for a digital hearing aid chip, allowing for real-time feedback and improved programmability.

The fabricated digital hearing aid chip, built using 0.18 microm CMOS technology, is compact (3.1 mm x 1.2 mm) and energy-efficient, consuming less than 120 microamperes, making it suitable for practical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The reference ear modeling method for internally feedback controlled digital hearing aid chip. Kim, S., Lee, SJ., Cho, N., et al.[2020]

Osseointegrated auditory implants like Baha(®) effectively deliver sound and amplify hearing for patients with conductive or mixed hearing loss and single-sided sensorineural deafness, addressing key challenges in bone conduction hearing.

Recent advancements in technology, such as computer-based fitting software and automatic directional microphones, enhance the hearing performance of Baha users, particularly in noisy environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges and recent developments in sound processing for Baha®. Flynn, MC.[2019]

The study introduced a new noise reduction system for cochlear implants, called NC+DDAE_T, which uses knowledge transfer technology to reduce the number of parameters needed while maintaining similar performance to the previous NC+DDAE model.

Testing with 10 cochlear implant users showed that the NC+DDAE_T system performed well in noisy conditions, potentially lowering implementation costs and improving the listening experience for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Environment-Aware-Based Noise Reduction System for Cochlear Implant Users Based on a Knowledge Transfer Approach: Development and Usability Study. Li, LP., Han, JY., Zheng, WZ., et al.[2021]

A new deep neural network (DNN) called 'Deep ACE' has been developed to enhance cochlear implant (CI) performance by effectively removing background noise while maintaining the quality of sound coding, which is crucial for users with profound hearing loss.

In tests with eight CI users, Deep ACE significantly improved speech intelligibility scores compared to traditional sound coding strategies, indicating its potential to enhance hearing in noisy environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Deep Denoising Sound Coding Strategy for Cochlear Implants. Gajecki, T., Zhang, Y., Nogueira, W.[2023]

A direct acoustic cochlear implant successfully improved hearing in a 47-year-old male with severe mixed hearing loss due to otosclerosis, raising his speech recognition score from 10% to 100%.

The restoration of hearing not only enhanced the patient's auditory capabilities but also led to a significant reduction in auditory hallucinations and allowed for a decrease in psychiatric medication, highlighting the link between hearing loss and psychosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful hearing improvement with direct acoustic stimulation in a patient with schizophrenia. Rebol, J., Kravos, M., Ložar, M.[2018]

Researchers developed advanced 'smart' hearing aids and cochlear implants using artificial intelligence to effectively filter out background noise, improving speech understanding in noisy environments.

This technology allows individuals with hearing loss to better engage in conversations in challenging settings, such as busy classrooms or restaurants, enhancing their social interactions and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Helping People Hear Better with "Smart" Hearing Devices. Goehring, T., Monaghan, J.[2022]

A new deep learning algorithm has been developed that effectively suppresses background noise while preserving speech signals, significantly improving speech intelligibility for hearing aid users to levels comparable to those with normal hearing.

This algorithm, trained on a large database of noisy speech, operates in real-time on a single microphone and shows promise for future integration into hearing aids, potentially enhancing the quality of life for millions of people with hearing loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoring speech intelligibility for hearing aid users with deep learning. Diehl, PU., Singer, Y., Zilly, H., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06743295

NCT06743295 | AI Noise Reduction in Phonak Hearing Aids The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for ...

2. clarityhearingcare.com clarityhearingcare.com/post/phonak-s-ai-driven-deep-sonic-chip-a-game-changer-in-speech-and-noise-separation

Phonak's AI-Driven Deep Sonic Chip: A Game-Changer in ... Their new AI-driven deep sonic chip promises to revolutionize how users experience sound by improving the separation of speech and background ...

3. phonakmarketing.com.au phonakmarketing.com.au/wp-content/uploads/2025/04/PH_Brochure_Infinio_210x297_EN-AU_028-2689-48_LR.pdf

Phonak Infinio: Unlock a world of possibilities Deep Sound Optimised Neural. Integrated Chip (DEEPSONIC) is the world's first proprietary DNN sound processing chip in a hearing aid. It has. 53x more ...

4. phonak.com phonak.com/content/dam/phonak/en/evidence-library/white-paper/technical-paper/PH_Insight_SphericSpeechClarity_210x297_EN_028-2684-02_V1.00.pdf

Revolutionary Speech Understanding with Spheric ... DEEPSONIC™ can accelerate a large variety of different neural network types and provides tremendous flexibility for future applications. Introduction. Ambient ...

5. thehearingsolution.com thehearingsolution.com/hearing-blog/transforming-hearing-aids-how-ai-and-deep-neural-networks-enhance-listening-experience

Transforming Hearing Aids: How AI and Deep Neural ... The Phonak Audio Infinio introduces a groundbreaking advancement in hearing aids with its dedicated deep neural network chip, DEEPSONIC.

6. phonak.com phonak.com/en-us/hearing-devices/hearing-aids/audeo-sphere

AI Noise Cancelling Hearing Aid | Phonak Audéo Sphere™ ... Infinio Sphere Ultra uses our proprietary and powerful DEEPSONIC ™ AI chip, which separates speech from noise in real time. Discover DEEPSONIC.

7. earhealth.co.nz earhealth.co.nz/artificial-intelligence-and-hearing-aids/

Artificial Intelligence and the Future of Hearing Aids Phonak focuses on reliability and advanced sound clarity through proactive monitoring and its DEEPSONIC AI chip. Widex empowers wearers with ...

8. lacanadahearing.com lacanadahearing.com/blog/features-hearing-aids-leading-brands

Smart Features of Modern Hearing Aids From Leading ... ... DEEPSONIC chip handles real-time AI processing for enhanced speech clarity in noise. The Oticon Intent incorporates the world's first user-intent sensors ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06743295/ai-noise-reduction-in-phonak-hearing-aids

AI Noise Reduction in Phonak Hearing Aids The purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception.