SEDA for Hearing Loss

Recruiting in Palo Alto (17 mi)

Overseen by David M Landsberger, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Not cochlear implant user, under 12

No Placebo Group

Trial Summary

What is the purpose of this trial?

In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the SEDA treatment for hearing loss?

Research shows that enhancing the contrast in speech sounds can help people with hearing loss understand speech better, especially in noisy environments. This approach, similar to SEDA, has been shown to improve speech intelligibility for those with moderate to severe hearing loss. ^{1 2 3 4 5}

How is the SEDA treatment for hearing loss different from other treatments?

SEDA is unique because it enhances speech intelligibility by increasing the contrast between speech sounds and background noise, using a process that adjusts the auditory pattern of speech signals. This approach is different from traditional hearing aids that often rely on noise cancellation or amplification. ^{1 2 3 6 7}

Research Team

David M Landsberger, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for cochlear implant users who are at least 12 years old and have been using their implant for over six months. Participants must be post-lingually deafened, meaning they lost hearing after acquiring language skills, and considered able to complete the study by the principal investigator.

Inclusion Criteria

You have received a cochlear implant and have had at least 6 months of experience, no matter which company made the implant.

The doctor thinks I can understand and do the study tasks.

I am 12 years old or older.

Exclusion Criteria

I do not use a cochlear implant and am 12 years old or older.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimentation

Participants complete up to 4 experiments evaluating the SEDA algorithm in various listening situations

Up to 2 years

Multiple sessions, each lasting 4-6 hours

Follow-up

Participants are monitored for effectiveness and safety after the completion of experiments

4 weeks

Treatment Details

Interventions

• SEDA (Other)

Trial Overview The trial is testing a new noise reduction algorithm called SEDA in various listening environments. The goal is to see if it helps people with cochlear implants understand speech better when there's background noise.

Participant Groups

Group I: Cochlear Implant Users Experimental Treatment 1 Intervention

Participants will complete up to 4 experiments evaluating the use of the Speech Enhancement using Dynamic thresholding Approach (SEDA) algorithm. Each testing session will take between 4-6 hours to complete. Testing sessions will continue until the completion of the experiments.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Dr. Alec C. Kimmelman

NYU Langone Health

Chief Executive Officer

MD and PhD from Mount Sinai School of Medicine

Dr. Nicole M. Adler

NYU Langone Health

Chief Medical Officer since 2023

MD

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA

Findings from Research

The speech-enhancement process developed for hearing-impaired listeners significantly improved speech intelligibility in noisy environments, particularly at speech-to-noise ratios between -3 and 6 dB.

This enhancement technique, which modifies the auditory excitation pattern of speech signals, showed small but meaningful improvements for subjects with moderate to severe sensorineural hearing loss, indicating its potential effectiveness in real-world listening situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral Enhancement to Improve the Intelligibility of Speech in Noise for Hearing-impaired Listeners. Simpson, AM., Moore, BCJ., Glasberg, BR.[2020]

The speech-enhancement process developed for hearing-impaired listeners significantly improved speech intelligibility in noisy environments, particularly at speech-to-noise ratios between -3 and 6 dB.

This enhancement technique, which modifies the auditory excitation pattern of speech signals, showed small but meaningful improvements for subjects with moderate to severe sensorineural hearing loss, indicating its potential effectiveness in real-world listening situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spectral enhancement to improve the intelligibility of speech in noise for hearing-impaired listeners. Simpson, AM., Moore, BC., Glasberg, BR.[2008]

The proposed deep learning-based speech enhancement method, combined with an optical microphone, significantly improves speech quality and comprehension for hearing-impaired individuals, outperforming traditional methods by notable margins.

This innovative approach effectively reduces background noise and interference from distance, suggesting a promising solution for enhancing the listening experience in challenging auditory environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical Microphone-Based Speech Reconstruction System With Deep Learning for Individuals With Hearing Loss. Lin, YM., Han, JY., Lin, CH., et al.[2023]

In a trial with 8 subjects who had bilateral sensorineural hearing loss, both hearing aids improved speech intelligibility in quiet environments compared to no aid, especially at lower sound levels.

Hearing aid A, which included two-channel syllabic compression along with automatic gain control, outperformed hearing aid B in noisy situations, demonstrating better speech recognition and lower speech reception thresholds, indicating its potential for enhanced performance in challenging listening environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of two-channel and single-channel compression hearing aids. Moore, BC., Glasberg, BR.[2015]

A speech enhancement scheme using spectral expansion and linear filtering improved speech reception thresholds (SRT) by about 1 dB for normal-hearing subjects with simulated frequency selectivity loss, indicating potential benefits for hearing-impaired listeners.

The combination of spectral expansion and linear filtering was more effective than using either method alone, but adding noise suppression did not provide additional improvements in SRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A speech enhancement scheme incorporating spectral expansion evaluated with simulated loss of frequency selectivity. Lyzenga, J., Festen, JM., Houtgast, T.[2019]

Signal-processing techniques can enhance hearing in noisy environments for individuals using monaural hearing aids or cochlear implants, compensating for the lack of binaural hearing.

The study introduces effective methods like noise cancellation and beam forming, which adaptively filter sounds based on distinguishing between noise and speech, improving the clarity of targeted sounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing Aids Using Binaural Processing Principles. Van Compernolle, D.[2020]

Signal-processing techniques can enhance hearing in noisy environments for individuals using monaural hearing aids or cochlear implants, compensating for the lack of binaural hearing.

The study introduces effective methods like noise cancellation and beam forming, which adaptively filter sounds based on distinguishing between noise and speech, improving the clarity of targeted sounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hearing aids using binaural processing principles. Van Compernolle, D.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Spectral Enhancement to Improve the Intelligibility of Speech in Noise for Hearing-impaired Listeners. [2020]

2. Norway pubmed.ncbi.nlm.nih.gov

Spectral enhancement to improve the intelligibility of speech in noise for hearing-impaired listeners. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Optical Microphone-Based Speech Reconstruction System With Deep Learning for Individuals With Hearing Loss. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A comparison of two-channel and single-channel compression hearing aids. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

A speech enhancement scheme incorporating spectral expansion evaluated with simulated loss of frequency selectivity. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Hearing Aids Using Binaural Processing Principles. [2020]

7. Norway pubmed.ncbi.nlm.nih.gov

Hearing aids using binaural processing principles. [2008]