NCT01670006

Brief Summary

The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is that restoration of hearing in the deafened ear will result in improved speech perception in the treated ear and advantages related to restoration of hearing to both ears.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
6.6 years until next milestone

Results Posted

Study results publicly available

September 22, 2022

Completed
Last Updated

September 22, 2022

Status Verified

August 1, 2022

Enrollment Period

2.5 years

First QC Date

August 17, 2012

Results QC Date

June 29, 2022

Last Update Submit

August 31, 2022

Conditions

Single Sided Deafness

Keywords

Single sided deafnessUnilateral deafnessUnilateral hearing lossCochlear implantation

Outcome Measures

Primary Outcomes (1)

  • Number of Subjects With Adverse Events

    Device and procedure-related anticipated and unanticipated aderse events.

    12 months

Secondary Outcomes (1)

  • Hearing in Noise Test (HINT)Score

    12 months

Study Arms (1)

Cochlear Implantation

EXPERIMENTAL

Cochlear Nucleus Cochlear Implant System

Device: Cochlear Nucleus Cochlear Implant System

Interventions

Cochlear Nucleus Cochlear Implant SystemDEVICE
Cochlear Implantation

Eligibility Criteria

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

You may qualify if:

  • Ability to provide informed consent.
  • Eighteen years-of-age or older at the time of implantation.
  • Presence of single-sided deafness as follows:
  • Poorer ear (ear to be implanted):
  • severe to profound sensorineural hearing loss, defined as pure-tone thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz.
  • Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 10%.
  • Better ear (contralateral ear):
  • Normal or near-normal hearing, defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz.
  • Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 90%.
  • Duration of severe to profound sensorineural hearing loss of at least 6 months (to ensure stability of hearing loss) but no greater than 10 years.
  • English spoken as a primary language.

You may not qualify if:

  • Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator.
  • Actively using an implantable device in the poorer ear.
  • Onset of severe to profound hearing loss \< 6 years-of-age.
  • Evidence of active middle-ear pathology based on otologic examination and/or immittance testing.
  • Medical or psychological conditions that contraindicate undergoing surgery.
  • Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array.
  • Hearing loss of neural or central origin, including auditory neuropathy.
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device.
  • Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
PRS Specialist, Clinical Affairs
Organization
Cochlear
cltd-prs-admin@cochlear.com
+612 9428 6555

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

August 17, 2012

First Posted

August 21, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2015

Study Completion

February 1, 2016

Last Updated

September 22, 2022

Results First Posted

September 22, 2022

Record last verified: 2022-08

Locations

US(1)