Hearing LossNCT01337076
Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
A study testing cochlear implant in people with Hearing Loss, run by Cochlear at 1 site in United States.
Trial summary
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- cochlear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jan 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eighteen years of age or older at the time of the study.
- Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear
- Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
- Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation.
- English spoken as the primary language.
Who cannot join
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- Active middle-ear infection.
- Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Trial locations and contacts
1 site in 1 country.
About this study
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.
Read the detailed description
Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (HINT) in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.
- Conditions
- Hearing Loss
- Being tested
- cochlear implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cochlear implantDevice
Also called implantable hearing device
Cochlear implant surgery
| Study group | Role | What they receive |
|---|---|---|
| cochlear implant | Other | Not described Receives: Device: cochlear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNC Monosyllabic Word Score - Treated Ear
The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements.
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJan 2014
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 Hearing LossStudies 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Colin Driscoll, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337076
- Sponsor's protocol ID
- CAM-EXP-A2010-01
- Status last verified
- Sep 2016
- First submitted
- 14 Apr 2011
- Last updated
- 27 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy
- ClinicalTrials.gov ID
- NCT01337076
- Acronym / sponsor ID
- CAM-EXP-A2010-01
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Posted 25 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.
Detailed description
Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (HINT) in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cochlear implant | Other | Device: cochlear implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eighteen years of age or older at the time of the study.
- Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear
- Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
- Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation.
- English spoken as the primary language.
Key exclusion criteria (6 listed)
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- Active middle-ear infection.
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 implantAlso: implantable hearing deviceCochlear implant surgery | Device | cochlear implant |
Primary outcome
CNC Monosyllabic Word Score - Treated Ear
Time frame: Six months
The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Colin Driscoll, MD principal investigator
Mayo Clinic
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 implant in people with Hearing Loss, 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 5 inclusion and 6 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 27 Oct 2016. 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 25 Sep 2014). 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?
CNC Monosyllabic Word Score - Treated Ear (time frame: Six 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 27 Oct 2016.