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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Dalhousie University, Department of Surgery, Division of Otolaryngology
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • The Ottawa Hospital, Parkdale Clinic, Audiology Department
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Advanced Bionics

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 8, 2013
• First Submitted That Met QC Criteria: October 8, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): May 21, 2015
• Last Update Submitted That Met QC Criteria: May 20, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Adults; Cochlear Implant; Electrical Stimulation; HiRes™ 90K Advantage implant; Cochlear Implantation; HiFocus™ Mid-Scala electrode; Listening Benefits; Cochlear Implant Benefit; HiRes Fidelity 120™
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Sensation Disorders; Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Imidacloprid
• Other Study ID Numbers: CR0513