Noninvasive Cochlear Stimulation System

NCT05112809 | Completed Results FDA Device

• 1 other identifier: 21-007158
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to develop a portable wearable hardware headset using a computer-based software that can establish the optimal stimulation parameters appropriate for medical and consumer environments for individuals with hearing impaired and normal hearing individuals.

Conditions

Healthy

Keywords

Normal hearing

Outcome Measures

Primary Outcomes (3)

• Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies

  Evaluated by increasing the amplitude of the current input until the subject could hear a tone at 250 Hz, 500 Hz, 1,000 Hz, 2,000 Hz, 4,000 Hz, 8,000 Hz, 10,000 Hz, 12,500 Hz and 16,000 Hz. The mean electric current is reported in Milliampere (mA).

  Baseline, approximately 2 hours

• Speech Intelligibility in Quiet Environment

  Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet environment. Electrodes were placed at 3 unique locations (forehead, mastoid, neck) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome 2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome 3).

  Baseline, approximately 2 hours

• Speech Intelligibility in Quiet and Noisy Environments

  Measured using the modified rhyme test (MRT) consisting of a set of 50 six-item wordlist. Each word list contains single syllable words with a consonant-vowel-consonant sound sequence. Subjects completed electrical word recognition testing in a quiet, then a noisy environment. Electrodes were placed at 3 unique locations (mastoid, wrist, back) to measure how well speech could be delivered to the subject through the skin electrodes in a manner that would allow subjects to recognize words in a quiet and noisy environment. There were 2 experiments done for speech intelligibility. The first involved 20 subjects (outcome2) and aimed to assess speech intelligibility performance in a basic, quiet environment without background noise. This phase focused on evaluating the fundamental hearing performance. Once it was established that speech intelligibility was satisfactory with electrical stimulation, we proceeded to test an additional 30 subjects in both quiet and noisy environments (outcome3)

  Baseline; approximately 2 hours

Study Arms (3)

Normal hearing subjects

EXPERIMENTAL

Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.

Device: Cochlear Stimulation System (CSS)

Bilateral hearing impaired

EXPERIMENTAL

Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.

Device: Cochlear Stimulation System (CSS)

Asymmetrical hearing-impaired

EXPERIMENTAL

Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.

Device: Cochlear Stimulation System (CSS)

Interventions

Cochlear Stimulation System (CSS) DEVICE

Cochlear stimulation with surround sound and noise cancellation

Asymmetrical hearing-impaired; Bilateral hearing impaired; Normal hearing subjects

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Employee of Mayo Clinic.

You may not qualify if:

• Pregnant.
• Cochlear implants.
• History of fluctuating sensorineural hearing loss.
• Skin diseases of the head.
• History of acute paroxysmal tachycardia.
• History of trigeminal neuralgia.
• Recent of paralysis of the facial nerve.
• Recent cerebrovascular stroke.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Publications (1)

• Kingsbury SE, Cevette MJ, Stepanek J, Pradhan GN. Investigating Speech Intelligibility Capabilities of Electrical Auditory Stimulation. Mil Med. 2026 Mar 1;191(3-4):e592-e600. doi: 10.1093/milmed/usaf430.

  PMID: 40899906 DERIVED

Related Links

• Mayo Clinic Clinical Trials

Results Point of Contact

• Title: Michael Cevette, Ph.D.
• Organization: Mayo Clinic

mcevette@mayo.edu

480-301-4380

Study Officials

• Michael J Cevette, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 28, 2021
• First Posted: November 9, 2021
• Study Start: October 6, 2023
• Primary Completion: December 20, 2024
• Study Completion: February 6, 2025
• Last Updated: December 30, 2025
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Locations

US (1)