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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02189798
• Other study ID #: CR0114
• Status: Terminated
• Phase: N/A
• Start date: October 21, 2014
• Est. completion date: March 29, 2022

Study information

• Verified date: July 2022
• Source: Advanced Bionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 29, 2022
• Est. primary completion date: March 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Ear Diseases
• Hearing Disorders
• Hearing Loss
• Otorhinolaryngologic Diseases
• Partial Deafness

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Austin Ear, Nose & Throat Clinic	Austin	Texas
United States	University of Missouri	Columbia	Missouri
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	Vanderbilt Bill Wilkerson Center	Nashville	Tennessee
United States	New York University Langone Medical Center	New York	New York
United States	Oklahoma Ear Institute	Oklahoma City	Oklahoma
United States	Mayo Clinic Rochester	Rochester	Minnesota
United States	Midwest Ear Institute/St. Luke's Health System	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	Tampa Bay Hearing and Balance Center	Tampa	Florida
United States	Georgetown University School of Medicine	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Bionics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unaided pure-tone hearing threshold measurements	Unaided pure tone hearing threshold measurement in the implanted ear 3 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)	Three months
Primary	Speech perception testing	Speech perception testing (in quiet and noise) in the treated ear compared to pre-implant speech perception testing (in quiet and noise)	Up to 19 months
Primary	Questionnaire data	Speech, Spatial Qualities (SSQ) questionnaire, Abbreviated Profile of Hearing Aid Benefits (APHAB) and Sponsored Development questionnaires post-implant compared to pre-implant condition	Up to 19 months