Clinical trial NCT02189798: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
Partial Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
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)
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2014-07-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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

Brief 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

Primary outcomes:
measure: Unaided Pure-tone Average (PTA) Hearing Threshold Measurements
timeFrame: Twelve months post device activation
measure: Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet
timeFrame: Up to 12 months post device activation
measure: Speech Perception Testing (AzBio) in Noise.
timeFrame: up to 12 months post device activation
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University School of Medicine
state: District of Columbia
city: Tampa
country: United States
facility: Tampa Bay Hearing and Balance Center
state: Florida
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Louis
country: United States
facility: Midwest Ear Institute/St. Luke's Health System
state: Missouri
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Ear Institute
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt Bill Wilkerson Center
state: Tennessee
city: Austin
country: United States
facility: Austin Ear, Nose & Throat Clinic
state: Texas
Study officials:
References: