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NCT05112809

Noninvasive Cochlear Stimulation System

Completed NA Results posted Last updated 30 December 2025
What this trial tests

NA trial testing Cochlear Stimulation System (CSS) in Healthy in 68 participants. Completed in 6 February 2025.

Timeline
6 October 2023
Primary endpoint
20 December 2024
6 February 2025

Quick facts

Lead sponsorMayo Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment68
Start date6 October 2023
Primary completion20 December 2024
Estimated completion6 February 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

Adults 21 to 75, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies Primary · Baseline, approximately 2 hours

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).

250 Hz
GroupValue95% CI
Normal Hearing Subjects2.16± 1.07
Bilateral Hearing Impaired2.88± 1.44
Asymmetrical Hearing-impaired2.88± 0.97
500 Hz
GroupValue95% CI
Normal Hearing Subjects1.86± 1.62
Bilateral Hearing Impaired2.93± 1.42
Asymmetrical Hearing-impaired2.40± 1.14
1,000 Hz
GroupValue95% CI
Normal Hearing Subjects1.09± 0.42
Bilateral Hearing Impaired1.75± 0.53
Asymmetrical Hearing-impaired1.70± 0.42
2,000 Hz
GroupValue95% CI
Normal Hearing Subjects1.29± 0.43
Bilateral Hearing Impaired1.77± 0.81
Asymmetrical Hearing-impaired1.71± 0.60
4,000 Hz
GroupValue95% CI
Normal Hearing Subjects1.56± 0.67
Bilateral Hearing Impaired3.50± 2.35
Asymmetrical Hearing-impaired1.84± 0.68
8,000 Hz
GroupValue95% CI
Normal Hearing Subjects1.71± 0.79
Bilateral Hearing Impaired2.25± 1.06
Asymmetrical Hearing-impaired3.00± 1.76
10,000 Hz
GroupValue95% CI
Normal Hearing Subjects1.97± 1.06
Bilateral Hearing Impaired3.25± 1.06
Asymmetrical Hearing-impaired3.96± 2.51
12,500 Hz
GroupValue95% CI
Normal Hearing Subjects2.29± 1.32
Bilateral Hearing Impaired6.00± 3.46
Asymmetrical Hearing-impaired3.67± 1.47
Speech Intelligibility in Quiet Environment Primary · Baseline, approximately 2 hours

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 (outco

Forehead
GroupValue95% CI
Normal Hearing Subjects84.38± 14.9
Mastoid
GroupValue95% CI
Normal Hearing Subjects94.06± 5.9
Neck
GroupValue95% CI
Normal Hearing Subjects84.06± 11.6
Speech Intelligibility in Quiet and Noisy Environments Primary · Baseline; approximately 2 hours

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 involv

Mastoid-Quiet Environment
GroupValue95% CI
Normal Hearing Subjects93.86± 8.2
Wrist-Quiet Environment
GroupValue95% CI
Normal Hearing Subjects93± 9.7
Back-Quiet Environment
GroupValue95% CI
Normal Hearing Subjects93.83± 10.2
Mastoid-Noisy Environment
GroupValue95% CI
Normal Hearing Subjects85.37± 11.7
Wrist-Noisy Environment
GroupValue95% CI
Normal Hearing Subjects86± 12.7
Back-Noisy Environment
GroupValue95% CI
Normal Hearing Subjects82.07± 12.5

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Investigating Speech Intelligibility Capabilities of Electrical Auditory Stimulation.
    Kingsbury SE, Cevette MJ, Stepanek J, Pradhan GN. · · 2026 · PMID 40899906 · DOI 10.1093/milmed/usaf430

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Other recruiting trials for Healthy

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05112809.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing