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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-21

Study Completion Date

2022-03-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Hearing Loss Partial Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode

Intervention Type DEVICE

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).

EAS sound processor

Intervention Type DEVICE

Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

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.

Group Type EXPERIMENTAL

EAS sound processor

Intervention Type DEVICE

Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

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.

Group Type EXPERIMENTAL

EAS sound processor

Intervention Type DEVICE

Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

Interventions

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HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).

Intervention Type DEVICE

EAS sound processor

Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Exclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No