NCT01959152

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

May 21, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

October 8, 2013

Last Update Submit

May 20, 2015

Conditions

Hearing LossDeafnessHearing DisordersEar DiseasesOtorhinolaryngologic Diseases

Keywords

Cochlear ImplantHiRes™ 90K Advantage implantCochlear ImplantationHiFocus™ Mid-Scala electrodeListening BenefitsAdultsCochlear Implant BenefitHiRes Fidelity 120™Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Word recognition in quiet pre and post implantation with the HiFocus™ Mid-Scala electrode array

    One month

Study Arms (1)

HiRes90K™ Advantage Cochlear Implant

EXPERIMENTAL

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

Interventions

HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrodeDEVICE
HiRes90K™ Advantage Cochlear Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • No previous cochlear implant experience
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dalhousie University, Department of Surgery, Division of Otolaryngology

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

The Ottawa Hospital, Parkdale Clinic, Audiology Department

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences Centre, Department of Otolaryngology - Head and Neck Surgery

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Hearing LossDeafnessHearing DisordersEar DiseasesOtorhinolaryngologic Diseases

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2013

First Posted

October 9, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2014

Study Completion

November 1, 2014

Last Updated

May 21, 2015

Record last verified: 2015-04

Locations

CA(3)