Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hearing Loss
- Sponsor
- Advanced Bionics
- Enrollment
- 1
- Locations
- 3
- Primary Endpoint
- Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
Time Frame: One month
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
Secondary Outcomes
- Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array(One month)