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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01959152
Other study ID # CR0513
Secondary ID
Status Terminated
Phase N/A
First received October 8, 2013
Last updated May 20, 2015
Start date October 2013
Est. completion date November 2014

Study information

Verified date April 2015
Source Advanced Bionics
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date November 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Device:
HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode


Locations

Country Name City State
Canada 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

Sponsors (1)

Lead Sponsor Collaborator
Advanced Bionics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array Unaided low-frequency acoustic hearing thresholds (under earphones) in the implanted ear one month after device activation will be compared to baseline (pre-implant) thresholds in the same ear for audiometric frequencies 125-1000Hz. Threshold changes from baseline will be calculated as:
Complete preservation of hearing: threshold shift = 15 dB
Partial preservation of hearing: threshold shift = 16 dB with measurable thresholds
No preservation of hearing: no measurable thresholds at = 80 dB HL
One month Yes
Secondary Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid One month No
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