Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode

Not Applicable

Terminated

• Conditions: Hearing Disorders; Deafness; Ear Diseases; Hearing Loss; Otorhinolaryngologic Diseases
• Interventions: Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode

• Registration Number: NCT01959152
• Lead Sponsor: Advanced Bionics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Primary Completion: 2014-09
• Study Completion: 2014-11
• Status Verified: 2015-04
• Last Update Submitted: 2015-05-20
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HiRes90K™ Advantage Cochlear Implant	HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

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