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.
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