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

Conditions: Hearing Loss; Partial Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases

Summary: 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).


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

Keywords: cochlear implant hires™ 90k advantage implant cochlear implantation hifocus™ mid-scala electrode listening benefits adults cochlear implant benefit electrical stimulation electro-acoustic stimulation (eas)