Clinical trial NCT01959152: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Official title: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hearing Loss
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
HiRes Fidelity 120™
Electrical Stimulation
Lead sponsor: Advanced Bionics
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 1
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 study is to determine the feasibility of preserving low-frequency acoustic hearing in adults with a moderate degree of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies who are implanted with the HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode.


Eligibility criteria: Inclusion Criteria:

* No previous cochlear implant experience
* 18 years of age or older
* Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL 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, 4,000, and 8,000 Hz) in the ear to be implanted
* Aided monosyllabic word score of 10-50% in the ear to be implanted
* Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone average ≤ 65 dB HL 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, 4,000, and 8,000 Hz) in the contralateral (non-implanted) ear
* English language proficiency
* Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria:

* Previous inner ear surgery
* Cochlear malformation or obstruction that would preclude full insertion of electrode array
* Presence of additional disabilities that would prevent or interfere with participation in the required study procedures
* Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study-related procedures
* Evidence of central auditory lesion or compromised auditory nerve

Primary outcomes:
measure: Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
timeFrame: One month
Secondary outcomes:
measure: Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array
timeFrame: One month
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Dalhousie University, Department of Surgery, Division of Otolaryngology
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital, Parkdale Clinic, Audiology Department
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery
state: Ontario
Study officials:
References: