Noninvasive Cochlear Stimulation System

Not Applicable

• Conditions: Healthy
• Interventions: Device: Cochlear Stimulation System (CSS)

• Registration Number: NCT05112809
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-09
• Study Start: 2023-10-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Employee of Mayo Clinic.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asymmetrical hearing-impaired	Cochlear Stimulation System (CSS)	Subjects with asymmetrical hearing-impairment will have a standard hearing test utilizing the cochlear stimulation system.
Normal hearing subjects	Cochlear Stimulation System (CSS)	Subjects with normal hearing will have a standard hearing test utilizing the cochlear stimulation system.
Bilateral hearing impaired	Cochlear Stimulation System (CSS)	Subjects with bilateral hearing impairment will have a standard hearing test utilizing the cochlear stimulation system.

Primary Outcome Measures

Name	Time	Method
Perception threshold	Baseline, approximately 2 hours	Evaluated by increasing the amplitude of the current input until the subject can hear a tone. The threshold will be recorded as the perception threshold at that electrode pair and frequency. Reported in hertz (Hz).
Speech Intelligibility	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.

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States