Single Sided DeafnessNCT01670006
Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
A study testing Cochlear Nucleus Cochlear Implant System in people with Single Sided Deafness, run by Cochlear at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Single Sided Deafness
- What is being tested?
- Cochlear Nucleus Cochlear Implant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University Medical Center
New York, New York, 10016
About this study
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.
- Conditions
- Single Sided Deafness
- Being tested
- Cochlear Nucleus Cochlear Implant System
- Keywords
- Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation
- Medical subject headings
- Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear Nucleus Cochlear Implant SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Cochlear Implantation | Experimental | Cochlear Nucleus Cochlear Implant System Receives: Device: Cochlear Nucleus Cochlear Implant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events
Device and procedure-related anticipated and unanticipated aderse events.
Measured: 12 months
Secondary outcomes (1)
Hearing in Noise Test (HINT)Score
To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Single Sided DeafnessStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670006
- Sponsor's protocol ID
- CAM5397
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2012
- Last updated
- 22 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness
- ClinicalTrials.gov ID
- NCT01670006
- Acronym / sponsor ID
- CAM5397
- Conditions
- Single Sided Deafness
- Keywords
- Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Aug 2012 (estimated)
- Results
- Posted 22 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear Implantation | Experimental | Device: Cochlear Nucleus Cochlear Implant SystemCochlear Nucleus Cochlear Implant System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to provide informed consent.
- Eighteen years-of-age or older at the time of implantation.
- Presence of single-sided deafness as follows:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear Nucleus Cochlear Implant System | Device | Cochlear Implantation |
Primary outcome
Number of Subjects With Adverse Events
Time frame: 12 months
Device and procedure-related anticipated and unanticipated aderse events.
1 secondary outcome
Hearing in Noise Test (HINT)Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Single Sided Deafness
RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
Unilateral Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Active, not recruiting
Single-Sided Deafness and Asymmetric Hearing Loss
Hearing Loss, Unilateral, Hearing Loss, Sensorineural
Active, not recruiting
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
Hearing Loss, Unilateral, Deafness, Unilateral
Active, not recruiting
Pediatric Expansion Study of the Sentio System
Hearing Loss, Conductive, Hearing Loss, Mixed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cochlear Nucleus Cochlear Implant System in people with Single Sided Deafness, run by Cochlear at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2022.