Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness
Purpose
The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).
Conditions
- Hearing Loss
- Partial Deafness
- Hearing Disorders
- Ear Diseases
- Otorhinolaryngologic Diseases
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Newly Implanted Group: - Ability to provide informed consent - No previous cochlear implant experience in either ear - 18 years of age or older - Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the ear to be implanted - Aided CNC word recognition score up to 50% in ear to be implanted - Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear - Aided CNC word recognition score up to 80% in the contralateral ear - English language proficiency - Willingness to use an ear-level sound processor postoperatively for the duration of the study trial - Willingness to participate in all scheduled procedures outlined in the protocol
Exclusion Criteria
Newly Implanted Group: - Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or more in range of 500-1000 Hz in the ear to be implanted - Congenital hearing loss (for purpose of this study, onset prior to age 2 years*). *Based on critical period for speech and language development - Duration greater than 30 years of severe-to-profound high-frequency hearing loss - Cochlear malformation or obstruction that would preclude full insertion of electrode array in the ear to be implanted - Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator - Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear - Active middle-ear disease/infection in the ear to be implanted - Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator - Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups - Ability to provide informed consent - 18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor (i.e. Naída family device) - Postoperative unaided low frequency audiometric hearing thresholds in the treated ear up to 80 dB HL for at least one frequency from 125 - 1000 Hz - English Language Proficiency - Willingness to participate in all scheduled procedures outlined in the study protocol EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups - Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix® and HiFocus™ 1j electrode - Exclusive use of a body worn external sound processor - Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear - Postoperative unaided low frequency audiometric hearing thresholds in the treated ear exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- The two main arms are conducted in parallel. The third arm is optional for subjects who complete either of the two main arms using the EAS sound processor.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Newly Implanted Group |
HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness. Patients retaining considerable low frequency acoustic hearing after the surgery, will be fitted with the EAS sound processor. |
|
Experimental Existing Implanted Group |
Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor. |
|
Experimental EAS Extended Use Arm |
Adults who are unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness and completed the 12 Month visit using the EAS sound processor in either the Newly Implanted Group or Existing Implanted Group. |
|
Recruiting Locations
More Details
- NCT ID
- NCT02189798
- Status
- Terminated
- Sponsor
- Advanced Bionics