At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Able to provide informed consent and proficient in English
- ✓Willingness to participate in all scheduled procedures and use approved cochlear implant processing strategy
- ✓Ear to be implanted: Severe-to-profound sensorineural hearing loss >70 dB HL (pure tone average at 500, 1000, 2000, 4000 Hz)
- ✕Previous cochlear implant experience in either ear
- ✕Cochlear malformation or obstruction (ossification) that would prevent full electrode array insertion in implant ear
- ✕Medical or psychological conditions that contraindicate surgery or impair ability to manage implant device or comply with study procedures
- ✕Diagnosis of auditory neuropathy/dys-synchrony in either ear
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
In Brief
A clinical study evaluating HiResolution Bionic Cochlear Implant for Hearing Loss and 5 related conditions. Completed, enrolled 24 participants across 2 sites.
Detailed Summary
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
Study Details
Timeline
Interventions
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.