Trial record 18 of 101 for:    Open Studies | "Deafness"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Advanced Bionics
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics
ClinicalTrials.gov Identifier:
NCT01959152
First received: October 8, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Advanced Bionics:

Primary Outcome Measures:
  • Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array [ Time Frame: One month ] [ Designated as safety issue: Yes ]

    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:
  • Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array [ Time Frame: One month ] [ Designated as safety issue: No ]
    Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid


Estimated Enrollment: 15
Study Start Date: October 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01959152

Locations
Canada, Nova Scotia
Dalhousie University, Department of Surgery, Division of Otolaryngology Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: JoAnne Whittingham, M.Sc.    (613) 738-3907    jwhittingham@cheo.on.ca; jwhitt@uottawa.ca   
Principal Investigator: Manohar Bance, MD         
Canada, Ontario
The Ottawa Hospital, Parkdale Clinic, Audiology Department Not yet recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Adrienne Comeau-Grandy, M.Sc., Aud    (902) 492-8241    Adrienne.Comeau-Grandy@nshsc.nshealth.ca   
Principal Investigator: David Schramm, MD         
Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Leah Smith, MA, CCRA    (416) 480-6100 ext 85392    leah.smith@sunnybrook.ca   
Principal Investigator: Vincent Lin, MD         
Sponsors and Collaborators
Advanced Bionics
  More Information

No publications provided

Responsible Party: Advanced Bionics
ClinicalTrials.gov Identifier: NCT01959152     History of Changes
Other Study ID Numbers: CR0513
Study First Received: October 8, 2013
Last Updated: May 21, 2014
Health Authority: Canada: Health Canada

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:
Deafness
Hearing Loss
Ear Diseases
Otorhinolaryngologic Diseases
Hearing Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014