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

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

ArmDescriptionAssigned 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.
  • Device: 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).
  • 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.
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.
  • 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.
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.
  • 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.

Recruiting Locations

Vanderbilt Bill Wilkerson Center
Nashville, Tennessee 37232
Contact:
Ashudee Kirk
615-936-2491
ashudee.kirk@vumc.org

More Details

NCT ID
NCT02189798
Status
Recruiting
Sponsor
Advanced Bionics

Study Contact

Silke Thode, Ph.D.
clinicalresearch@advancedbionics.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.