N/A
N=68
Noninvasive Cochlear Stimulation System
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05112809 ↗Enrolled (actual)
68
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies — 2.16; 2.88; 2.88; 1.86 mA
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear Stimulation System (CSS) (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in Electric Current Subjects Indicated They Could Hear a Tone at Certain Frequencies |
2.16; 2.88; 2.88; 1.86; 2.93; 2.40 | — |
| PRIMARY Speech Intelligibility in Quiet Environment |
84.38; 94.06; 84.06 | — |
| PRIMARY Speech Intelligibility in Quiet and Noisy Environments |
93.86; 93; 93.83; 85.37; 86; 82.07 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Employee of Mayo Clinic.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05112809). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.