Deafness, Ear Diseases, Hearing Disorders, Hearing Loss, Otorhinolaryngologic Diseases
Conditions
Keywords
Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, HiRes Fidelity 120™, Electrical Stimulation
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.
Interventions
DEVICEHiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
Sponsors
Advanced Bionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array | 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
| Measure | Time frame | Description |
|---|---|---|
| Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array | One month | Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid |
Countries
Canada
Outcome results
None listed