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

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ClinicalTrials.gov Identifier: NCT01959152
Recruitment Status : Terminated
First Posted : October 9, 2013
Last Update Posted : May 21, 2015
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Device: HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Study Start Date : October 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959152


Locations
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Canada, Nova Scotia
Dalhousie University, Department of Surgery, Division of Otolaryngology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
The Ottawa Hospital, Parkdale Clinic, Audiology Department
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Advanced Bionics
More Information
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Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01959152    
Other Study ID Numbers: CR0513
First Posted: October 9, 2013    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: April 2015
Keywords provided by Advanced Bionics:
Cochlear Implant
HiRes™ 90K Advantage implant
Cochlear Implantation
HiFocus™ Mid-Scala electrode
Listening Benefits
 Adults
Cochlear Implant Benefit
HiRes Fidelity 120™
Electrical Stimulation
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs