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

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