Clinical trial NCT02811549: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Official title: Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Asymmetrical Hearing Loss
Single-Sided Deafness
Keywords: Cochlear Implant
HiRes™ 90K Advantage Implant
HiFocus™ Mid-Scala electrode
HiFocus™ 1J electrode
HiFocus Helix™ electrode
Cochlear Implantation
Listening Benefits
Adults
Cochlear Implant Benefit
Electrical Stimulation
HiRes™ Ultra Implant with HiFocus™ Mid-Scala electrode
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).


Eligibility criteria: Inclusion Criteria:

General Requirements:

* Ability to provide Informed Consent
* 18 years of age or older
* English language proficiency
* Willingness to participate in all scheduled procedures outlined in the study investigational plan
* Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study

Ear to be Implanted:

* Severe-to-profound sensorineural hearing loss (\> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
* CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
* Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) \>3 months and ≤10 years in the ear to be implanted only

Contralateral (non-implanted) ear:

* Up to a moderate sensorineural hearing loss (\<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
* CNC word recognition score \>30% (tested in subject's everyday listening condition for that ear)

Exclusion Criteria:

* Previous experience with a cochlear implant
* Cochlear malformation or obstruction (i.e. ossification) 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
* 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

Primary outcomes:
measure: Change in Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)
timeFrame: Baseline and Twelve months
measure: Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)
timeFrame: Baseline and Twelve months
measure: Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise Front
timeFrame: Baseline and Twelve months
measure: Change in Lateralization Ability Testing (Bilateral Listening Condition)
timeFrame: Baseline and Twelve months
measure: Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted Ear
timeFrame: Baseline to Twelve Months
measure: Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.
timeFrame: Baseline to Twelve Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: The Silverstein Institute
state: Florida
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
References: