Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
NCT ID: NCT01959152
Last Updated: 2015-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2013-10-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HiRes90K™ Advantage Cochlear Implant
HiRes90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with a moderate level of hearing loss in the low frequencies and severe-to-profound hearing loss in the mid-to-high frequencies.
HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
Interventions
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HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Advanced Bionics
INDUSTRY
Responsible Party
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Locations
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Dalhousie University, Department of Surgery, Division of Otolaryngology
Halifax, Nova Scotia, Canada
The Ottawa Hospital, Parkdale Clinic, Audiology Department
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CR0513
Identifier Type: -
Identifier Source: org_study_id
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