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
Hearing Loss, Partial Deafness, Hearing Disorders
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, Electrical Stimulation, Electro-Acoustic Stimulation (EAS)
Eligibility Criteria
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
Sites / Locations
- Georgetown University School of Medicine
- Tampa Bay Hearing and Balance Center
- University of Kentucky Medical Center
- Mayo Clinic Rochester
- University of Missouri
- Washington University
- Midwest Ear Institute/St. Luke's Health System
- New York University Langone Medical Center
- Oklahoma Ear Institute
- Vanderbilt Bill Wilkerson Center
- Austin Ear, Nose & Throat Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Newly Implanted Group
Existing Implanted Group
EAS Extended Use Arm
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.
Adults unilaterally implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode with partial deafness will be fitted with the EAS sound processor.
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.