Single-sided DeafnessSSDNCT02259192
Cochlear Implants for Adults With Single-sided Deafness
A study testing MED-EL Maestro Cochlear Implant in people with Single-sided Deafness, run by Robert Shannon at 2 sites in United States.
Trial summary
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). 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?
- MED-EL Maestro Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Is an adult (18 years of age or older)
- English as the primary language
- Able to undergo general anesthesia, as determined by physical examination and written report from the physician
- Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the principal investigator
- Profoundly/severely deaf in one ear ("implant ear"), as defined by:
- 3-frequency pure-tone average≥70 dB Hearing Loss
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- Bone conduction thresholds consistent with air conduction thresholds (i.e., no conductive component to the hearing loss)
- HINT sentence recognition score ≤40% correct, 60 dBA presentation level
- Post-lingual onset of hearing loss, i.e., after age 6 years of age
- Hearing loss occurred <10 years prior, as obtained by history
- Normal hearing in one ear ("non-implant ear"), as defined by:
- 3-frequency PTA ≤25 dB HL
- No tested frequency air conduction threshold >35 dB HL
- Bone conduction thresholds consistent with air conduction thresholds
- Word recognition score ≥80% correct, 60 dBA presentation level
- HINT sentence recognition score ≥ 80%, 60 dBA presentation level
- Provides informed consent
- Willing and able to follow the study protocol
Who cannot join
- Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial nerve/brainstem tumors
- Co-existing medical conditions that require radiotherapy of the brainstem and/or auditory cortex
- Any medical contraindication precluding safe administration of general anesthesia, e.g.,
- Cardiopulmonary disease
- Renal disease
- Otologic conditions which contraindicate surgery
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- Active middle ear infection
- Tympanic membrane perforation
- Anatomic abnormalities detected on CT preventing appropriate placement of the stimulator housing in the bone of the skull or placement of the electrode array in the cochlea (e.g., ossification)
- Psychological conditions contraindicating surgery
- Skin or scalp conditions that may preclude attachment of the coil or that may interfere with the use of the coil
- Chronic pain in or around the head
- Current or previous use of an active hearing implant (e.g., bone-anchored hearing aids, cochlear implant, etc.)
- Developmental delays or organic brain dysfunction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Keck School of Medicine of USC
Los Angeles, California, 90007
House Clinic
Los Angeles, California, 90057
About this study
Official title: Cochlear Implantation for Single-Sided Deafness
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.
- Conditions
- Single-sided Deafness
- Being tested
- MED-EL Maestro Cochlear Implant
- Keywords
- deaf adult, single-sided, cochlear implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-EL Maestro Cochlear ImplantDevice
cochlear implant
| Study group | Role | What they receive |
|---|---|---|
| Open-label | Experimental | Cochlear Implant Receives: Device: MED-EL Maestro Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pure-tone threshold average (dB)
Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
Measured: 6 months post-activation
Hearing in Noise Test (signal-to-noise ratio)
Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.
Measured: 6 months post-activation
Secondary outcomes (1)
Adverse Events
Number of unexpected serious adverse events across all 10 subjects.
Measured: 1-month post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single-sided DeafnessStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Shannon
- Sponsor type
- University, hospital or other
- Collaborators
- Med-El Corporation, House Clinic, Inc., University of California, Los Angeles
- Responsible party
- Sponsor-investigator, Robert Shannon, University of Southern California
- Investigators
- Robert Shannon, PhD, Principal investigator, Keck School of Medicine of USC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259192
- Sponsor's protocol ID
- CI for SSD adults
- Acronym
- SSD
- Status last verified
- Apr 2017
- First submitted
- 26 Sep 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear Implantation for Single-Sided Deafness
- ClinicalTrials.gov ID
- NCT02259192
- Acronym / sponsor ID
- SSD / CI for SSD adults
- Conditions
- Single-sided Deafness
- Keywords
- deaf adult, single-sided, cochlear implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Robert ShannonUniversity, hospital or other
- Collaborators
- Med-El Corporation, House Clinic, Inc., University of California, Los Angeles
- Study start
- Sep 2014
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open-label | Experimental | Device: MED-EL Maestro Cochlear ImplantCochlear Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Is an adult (18 years of age or older)
- English as the primary language
- Able to undergo general anesthesia, as determined by physical examination and written report from the physician
- Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the principal investigator
- Profoundly/severely deaf in one ear ("implant ear"), as defined by:
Key exclusion criteria (14 listed)
- Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial nerve/brainstem tumors
- Co-existing medical conditions that require radiotherapy of the brainstem and/or auditory cortex
- Any medical contraindication precluding safe administration of general anesthesia, e.g.,
- Otologic conditions which contraindicate surgery
- Anatomic abnormalities detected on CT preventing appropriate placement of the stimulator housing in the bone of the skull or placement of the electrode array in the cochlea (e.g., ossification)
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 |
|---|---|---|
| MED-EL Maestro Cochlear Implantcochlear implant | Device | Open-label |
Primary outcome
Pure-tone threshold average (dB)
Time frame: 6 months post-activation
Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
Hearing in Noise Test (signal-to-noise ratio)
Time frame: 6 months post-activation
Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.
1 secondary outcome
Adverse Events
Time frame: 1-month post-implantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
Related trials for Single-sided Deafness
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
Recruiting
The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users
Cochlear Implant, Sensorineural Hearing Loss
Recruiting
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
Sensorineural Hearing Loss, Cochlear Implantation
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.
Robert Shannon, PhD principal investigator
Keck School of Medicine of USC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED-EL Maestro Cochlear Implant in people with Single-sided Deafness, run by Robert Shannon at 2 sites 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 18 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Pure-tone threshold average (dB) (time frame: 6 months post-activation). The study lists 2 primary outcomes in all. 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 20 Apr 2017.