Auditory Implant Evaluation for Hearing Loss

Overseen By Mahan Azadpour

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Cognitive disorders, Neurological disorders, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

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 treatment Electrode-Neural Interface, Brain-Computer Interface (BCI), Brain-Machine Interface (BMI), Neural Interface, Electrode Array, Neuroprosthetic Device for hearing loss?

Research on auditory brainstem implants (ABI), a type of neuroprosthetic device, shows that having more active electrodes can improve hearing outcomes, such as word and sentence recognition, especially in children. However, the number of electrodes that can be effectively used varies, and better electrode positioning during surgery may lead to better hearing perception. ^{1 2 3 4 5}

Is the auditory brainstem implant generally safe for humans?

The auditory brainstem implant (ABI) has been used in various studies and clinical settings, including compassionate use protocols, suggesting it is generally considered safe for human use, although specific safety data is not detailed in the provided research articles. ^{1 6 7 8 9}

How is the Electrode-Neural Interface treatment for hearing loss different from other treatments?

The Electrode-Neural Interface, also known as a Brain-Computer Interface (BCI), is unique because it directly connects to the brain to help process auditory information, unlike traditional hearing aids or cochlear implants that amplify sound or stimulate the cochlea. This approach can potentially offer more precise auditory perception by bypassing damaged parts of the ear and directly interfacing with neural pathways. ^{1 4 5 10 11}

What is the purpose of this trial?

This is a basic investigational research study conducted with hearing impaired adults and children who use cochlear implant or auditory brainstem implant (ABI) devices. The study will evaluate different aspects of hearing and auditory processing in the users of implantable auditory devices.

Research Team

Mahan Azadpour

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for hearing-impaired adults and children over 2 years old who use cochlear or auditory brainstem implants. Participants must not have other cognitive or communicative disorders, severe neurological issues, and their implant's electrodes must be functional without causing discomfort.

Inclusion Criteria

Patients' implant device must have useable electrodes that do not result in uncomfortable or unpleasant non-auditory sensation.

I am hearing impaired and use an ABI or cochlear implant.

I have no cognitive disorders except for hearing impairment and can visit the lab.

Exclusion Criteria

You do not have functioning electrodes in your implants.

I have a severe neurological disorder.

You have trouble thinking clearly or communicating with others, except for hearing problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Measurement

Participants undergo perceptual and physiological measurements to evaluate auditory processing

1 day

1 visit (in-person, average length 3 hours)

Follow-up

Participants are monitored for any immediate effects or feedback after measurements

1-2 weeks

Treatment Details

Interventions

• Electrode-Neural Interface

Trial Overview The study investigates how well people with cochlear or auditory brainstem implants process sounds. It involves behavioral and electrophysiological experiments conducted in a lab setting to evaluate the effectiveness of these devices in restoring hearing functions.

Participant Groups

Group I: Hearing-Impaired Individuals who use Cochlear Implants or Auditory Brainstem Implant (ABI) Devices Experimental Treatment 1 Intervention

Two types of measurements will be obtained: 1. Perceptual: one or more sounds are presented and a behavioral response is collected (e.g., judgements of loudness, pitch or other differences between the sounds, or identifying the word or sentence that was said). 2. Physiological: noninvasive electrophysiological recordings of nervous system activity.

Electrode-Neural Interface is already approved in United States, European Union for the following indications:

Approved in United States as Utah Array for:

• Motor function restoration in paralyzed patients
• Clinical investigations of intracortical brain-machine interface technology

Approved in European Union as Cochlear Implants for:

• Severe to profound sensorineural hearing loss

Approved in United States as Auditory Brainstem Implants for:

• Severe to profound hearing loss, particularly in cases where cochlear implants are not suitable

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Cochlear Americas

Collaborator

Trials

1

Recruited

200+

Findings from Research

In a study of 61 patients with neurofibromatosis Type 2 who received an eight-electrode auditory brainstem implant (ABI), it was found that having at least three functional electrodes is necessary for satisfactory speech recognition, particularly in vowel and word recognition tests.

While increasing the number of electrodes beyond three can improve performance, no significant benefits were observed for patients with more than five active electrodes, suggesting that the limited frequency information provided by surface stimulation restricts the effectiveness of multichannel ABI systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The multichannel auditory brainstem implant: how many electrodes make sense? Kuchta, J., Otto, SR., Shannon, RV., et al.[2004]

In a study of 24 patients (16 adults and 8 children) with auditory brainstem implants (ABIs), it was found that the number of viable electrodes estimated during surgery often overestimated the actual number of active electrodes available for hearing after the procedure.

Long-term perceptual outcomes were significantly better in children compared to adults, with at least 11 active electrodes needed for good word detection and 14 for effective open-set recognition, highlighting the importance of electrode activation for successful hearing restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results. Veronese, S., Cambiaghi, M., Tommasi, N., et al.[2023]

The auditory brainstem implant (ABI) is a promising option for individuals, including children, with profound hearing loss who cannot receive cochlear implants due to anatomical issues, such as severe cochlear or cochlear nerve deformities.

While ABI outcomes for patients with neurofibromatosis type 2 (NF2) are modest compared to cochlear implants, recent studies indicate that some non-tumor adult and pediatric users can achieve speech perception, highlighting its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric Auditory Brainstem Implant Surgery: A New Option for Auditory Habilitation in Congenital Deafness? Shah, PV., Kozin, ED., Kaplan, AB., et al.[2018]

In a study involving 20 patients with mixed hearing loss, the multiple-channel nonlinear bone conduction implant (M-BCI) demonstrated significantly better speech perception in noisy environments compared to the single-channel linear bone conduction implant (S-BCI), with improvements of 1.7 dB in quiet and 5.8 dB in directional mode.

Patients reported a statistically significant subjective preference for the M-BCI over the S-BCI across all measured aspects, likely due to the M-BCI's enhanced high-frequency gain and improved signal processing strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of sound processing strategies for osseointegrated bone conduction implants in mixed hearing loss: multiple-channel nonlinear versus single-channel linear processing. Desmet, JB., Bosman, AJ., Snik, AF., et al.[2015]

The study analyzed the electrode array positions of 11 pediatric and adult auditory brainstem implant (ABI) users using postoperative imaging, revealing significant variability in array orientation that may affect auditory performance.

Differences in electrode array angles and positions were linked to variations in electrical thresholds and the number of active electrodes, suggesting that precise positioning of the ABI could be crucial for optimizing sound perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. Barber, SR., Kozin, ED., Remenschneider, AK., et al.[2018]

The auditory brainstem implant (ABI) is primarily used for patients with neurofibromatosis 2 (NF2) who have lost auditory nerve function due to bilateral vestibular schwannomas, allowing them to perceive sound sensations, mainly aiding in lipreading.

Out of five patients who received the ABI in the Czech Republic since 1999, one patient has achieved significant benefits by understanding speech without lipreading, while others primarily use the device to assist with lipreading, highlighting varying levels of efficacy among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of the auditory brainstem neuroprosthesis in the Czech Republic]. Skrivan, J., Zvĕrina, E., Betka, J., et al.[2006]

In a preliminary study involving seven patients with neurofibromatosis type 2 (NF2) who received either the Cochlear ABI541 or Med-El Synchrony ABI after vestibular schwannoma surgery, no complications were reported, indicating a strong safety profile for these devices.

Early audiometric performance with the Cochlear ABI541 and Med-El Synchrony ABI devices appears comparable to previous experiences with the Cochlear ABI24 device, suggesting their efficacy in restoring hearing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience. Roberts, DS., Slattery, WH., Chen, BS., et al.[2019]

The active transcutaneous bone conduction implant (BCI602) significantly improved hearing outcomes in 30 adult patients with single-sided deafness, showing a mean aided pure-tone threshold of 34.2 dB HL and enhanced speech discrimination and sound localization abilities.

Patients reported substantial subjective benefits, with significant improvements in communication ease and reduced tinnitus, indicating that the BCI602 device is both effective and safe for individuals with acquired single-sided deafness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. Kim, H., Park, MK., Park, SN., et al.[2023]

In a study of 10 patients with postmeningitis hearing loss, 80% experienced significant improvements in hearing and speech perception after receiving an auditory brainstem implant (ABI) via a safe surgical method over an average follow-up of 3.3 years.

The extended retrolabyrinthine approach for ABI implantation proved effective, allowing some patients to recognize up to 40% of closed-set sentences without lip-reading, demonstrating its potential as a rehabilitation option for those with ossified cochleae.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory brainstem implant in postmeningitis totally ossified cochleae. Malerbi, AFDS., Goffi-Gomez, MVS., Tsuji, RK., et al.[2018]

The SpiralE in-ear bioelectronics BCI achieved impressive offline accuracies of 95% in classifying visual stimuli and successfully allowed participants to type phrases in a calibration-free online experiment, showcasing its efficacy for communication and rehabilitation.

In addition to visual tasks, the in-ear device demonstrated an 84% accuracy in classifying natural speech in noisy environments, indicating its potential for practical applications in real-world auditory settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformal in-ear bioelectronics for visual and auditory brain-computer interfaces. Wang, Z., Shi, N., Zhang, Y., et al.[2023]

A profoundly hearing impaired subject demonstrated the ability to lateralize sounds based on interaural time delay and loudness differences, indicating effective bilateral cochlear implant functionality.

The study found that bilateral stimulation did not degrade speech processor performance and could enhance consonant identification, suggesting that coordinated binaural stimulation may improve speech understanding in noisy environments for cochlear implant users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral cochlear implants controlled by a single speech processor. Lawson, DT., Wilson, BS., Zerbi, M., et al.[2010]

References

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

The multichannel auditory brainstem implant: how many electrodes make sense? [2004]

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

Ten-year follow-up of auditory brainstem implants: From intra-operative electrical auditory brainstem responses to perceptual results. [2023]

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

Pediatric Auditory Brainstem Implant Surgery: A New Option for Auditory Habilitation in Congenital Deafness? [2018]

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

Comparison of sound processing strategies for osseointegrated bone conduction implants in mixed hearing loss: multiple-channel nonlinear versus single-channel linear processing. [2015]

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

Auditory Brainstem Implant Array Position Varies Widely Among Adult and Pediatric Patients and Is Associated With Perception. [2018]

6. Czech Republic pubmed.ncbi.nlm.nih.gov

[Use of the auditory brainstem neuroprosthesis in the Czech Republic]. [2006]

7. England pubmed.ncbi.nlm.nih.gov

'Compassionate use' protocol for auditory brainstem implantation in neurofibromatosis type 2: Early House Ear Institute experience. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of the Bonebridge BCI602 for Adult Patients with Single-sided Deafness: A Prospective Multicenter Study. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Auditory brainstem implant in postmeningitis totally ossified cochleae. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Conformal in-ear bioelectronics for visual and auditory brain-computer interfaces. [2023]

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

Bilateral cochlear implants controlled by a single speech processor. [2010]