search
Back to results

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

Primary Purpose

Hearing Loss, Deafness, Hearing Disorders

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
Sponsored by
Advanced Bionics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, HiRes Fidelity 120™, Electrical Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dalhousie University, Department of Surgery, Division of Otolaryngology
  • The Ottawa Hospital, Parkdale Clinic, Audiology Department
  • Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HiRes90K™ Advantage Cochlear Implant

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2013
Last Updated
May 20, 2015
Sponsor
Advanced Bionics
search

1. Study Identification

Unique Protocol Identification Number
NCT01959152
Brief Title
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Official Title
Evaluation of Hearing Preservation in Adults With Partial Low-Frequency Hearing Implanted With the HiFocus™ Mid-Scala Electrode
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
October 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases
Keywords
Cochlear Implant, HiRes™ 90K Advantage implant, Cochlear Implantation, HiFocus™ Mid-Scala electrode, Listening Benefits, Adults, Cochlear Implant Benefit, HiRes Fidelity 120™, Electrical Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HiRes90K™ Advantage Cochlear Implant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode
Primary Outcome Measure Information:
Title
Low-frequency unaided acoustic hearing thresholds pre and post implantation with the HiFocus™ Mid-Scala electrode array
Description
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
Time Frame
One month
Secondary Outcome Measure Information:
Title
Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array
Description
Word recognition scores in quiet in the implanted ear one month after device activation compared to pre-implant score with a hearing aid
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dalhousie University, Department of Surgery, Division of Otolaryngology
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Ottawa Hospital, Parkdale Clinic, Audiology Department
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs