Post-Market Clinical Investigation of the IotaSOFT Insertion System

Recruiting Observational Study
Hearing Loss, Cochlear Cochlear Implantation Hearing Loss, Sensorineural
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
12 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
iotaMotion, Inc. · Industry
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About This Trial

The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below: 1. Advanced Bionics HiFocus SlimJ 2. Cochlear Slim Straig…
Contacts

Laura Chenier, AuD

442-325-4171

lchenier@iotamotion.com

CONTACT

Wade Colburn

wcolburn@iotamotion.com

CONTACT