Hearing Loss, SensorineuralNCT03900897
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
A study testing MED-EL SYNCHRONY PIN Cochlear Implant and Cochlear Implant in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 8 sites in United States.
Trial summary
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit… Read more about this study
- Who is it for?
- Ages 7 months to 5 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- MED-EL SYNCHRONY PIN Cochlear Implant and Cochlear Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Jun 2019to 1 Nov 2023
- 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 7 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 7 months to 5 years 11 months of age at the time of implantation
- Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and
- For subjects implanted under 12 months of age: bilateral, severe to profound SNHL in the low frequencies
- For subjects implanted at 12 months to 5 years 11 months of age: bilateral, mild to profound sensorineural hearing loss in the low frequencies
- Insufficient functional access to sound with appropriately fit amplification and aural habilitation
- Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
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- Radiologic evidence of potential for full insertion with one of the included electrode arrays
- Ability to undergo general anesthesia
- At least one parent/guardian who is fluent in one of the available languages of the LEAQ
- Parental commitment to study parameters
Who cannot join
- Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
- Active middle ear infection
- Permanent conductive hearing loss
- Treatable mixed hearing loss
- Current or history of meningitis
- Common cavity
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- Skin or scalp condition precluding use of external audio processor
- Suspected cognitive impairment, organic brain dysfunction, or syndromic etiology that may affect performance
- ASA (American Society of Anesthesiologists) Class 3 or higher in subjects under 12 months of age
- History of prior use of a hearing implant
- Unrealistic parental/patient expectations
- Child is not able to complete speech perception testing in English
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27514
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
ENT for Children
Coppell, Texas, 75019
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Miami Health System
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
Oregon Health and Sciences University
Portland, Oregon, 97239-3098
About this study
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- MED-EL SYNCHRONY PIN Cochlear Implant, Cochlear Implant
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-EL SYNCHRONY PIN Cochlear ImplantDevice
Also called SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28, SYNCHRONY +FLEX24
Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.
Cochlear ImplantOther
Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.
| Study group | Role | What they receive |
|---|---|---|
| Prospective | Experimental | Detailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling. Receives: Device: MED-EL SYNCHRONY PIN Cochlear Implant |
| Retrospective | Other | Study identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation. Receives: Other: Cochlear Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Clinical success defined as a Total Score of 25 or more on the LittLEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills.
Measured: Up to 12 Months Post-Activation
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.
Measured: Up to 12 Months Post-Activation
Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
Adverse events will be collected and reported throughout the duration of the study.
Measured: Up to 12 Months Post-Activation
Secondary outcomes (3)
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Change from baseline in Total Score on the LittlEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills. The LittlEARS Auditory Questionnaire is intended for young children with zero to 24 months of listening experience.
Measured: Up to 12 Months Post-Activation
Total Score on Auditory Skills Checklist (ASC)
Change from baseline in Total Score on the Auditory Skills Checklist (ASC). Total Score ranges from zero to 70, with higher scores indicating development of increasingly complex listening skills. The Auditory Skills Checklist is intended for children from zero to 18 years of age.
Measured: Up to 12 Months Post-Activation
Speech recognition testing in the implanted ear(s)
Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise.
Measured: Up to 12 Month Post-Activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start17 Jun 2019
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Multicenter, open-label, non-randomized, repeated-measures design with two study arms as follows. Prospective: interventional study arm with prospective enrollment and treatment through one year of implant use. Retrospective: observational study arm with retrospective protocol for systematic chart review of patients with at least one year of implant use.
- Masking
- None (open label)
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Med-El Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900897
- Sponsor's protocol ID
- G180269
- Status last verified
- Oct 2024
- First submitted
- 1 Apr 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
- ClinicalTrials.gov ID
- NCT03900897
- Acronym / sponsor ID
- G180269
- Conditions
- Hearing Loss, Sensorineural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Med-El CorporationIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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 demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet, continue to demonstrate insufficient functional access to sound with appropriately fit hearing aids and aural habilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, open-label, non-randomized, repeated-measures design with two study arms as follows. Prospective: interventional study arm with prospective enrollment and treatment through one year of implant use. Retrospective: observational study arm with retrospective protocol for systematic chart review of patients with at least one year of implant use.
| Arm | Type | Receives |
|---|---|---|
| Prospective | Experimental | Device: MED-EL SYNCHRONY PIN Cochlear ImplantDetailed interventions and outcome measures refer to the prospective, experimental study arm. The prospective arm is active but not enrolling. |
| Retrospective | Other | Other: Cochlear ImplantStudy identification, sponsor/collaborators, oversight, purpose, indications, and primary endpoints for the retrospective, observational study arm align with the prospective study arm. The retrospective arm will be enrolling by invitation for chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. The specific devices and outcome measures will vary slightly for retrospective subjects, based on what was clinically available and used at the time of implantation. |
Who may qualify
- Ages
- 7 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Children 7 months to 5 years 11 months of age at the time of implantation
- Bilateral, severe to profound sensorineural hearing loss (SNHL) in the high frequencies and
- Insufficient functional access to sound with appropriately fit amplification and aural habilitation
- Objective measures consistent with repeatable unaided audiometric thresholds for subjects under 12 months of age
- Radiologic evidence of potential for full insertion with one of the included electrode arrays
Key exclusion criteria (12 listed)
- Magnetic Resonance Imaging (MRI) evidence of cochlear nerve deficiency
- Active middle ear infection
- Permanent conductive hearing loss
- Treatable mixed hearing loss
- Current or history of meningitis
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 SYNCHRONY PIN Cochlear ImplantAlso: SYNCHRONY +FLEXSOFT, SYNCHRONY +FLEX28, SYNCHRONY +FLEX24Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors. | Device | Prospective |
| Cochlear ImplantChart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020. | Other | Retrospective |
Primary outcome
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Time frame: Up to 12 Months Post-Activation
Clinical success defined as a Total Score of 25 or more on the LittLEARS Auditory Questionnaire (LEAQ). Total Score ranges from zero to 35, with higher scores indicating development of increasingly complex listening skills.
Percent correct on Multisyllabic Lexical Neighborhood Test (MLNT)/Lexical Neighborhood Test (LNT)
Time frame: Up to 12 Months Post-Activation
Clinical success defined as an improvement of 10 percentage points or more on MLNT/LNT.
Number and proportion of subjects experiencing device- and/or procedure-related adverse events.
Time frame: Up to 12 Months Post-Activation
Adverse events will be collected and reported throughout the duration of the study.
3 secondary outcomes
Total Score on LittlEARS Auditory Questionnaire (LEAQ)
Time frame: Up to 12 Months Post-Activation
Total Score on Auditory Skills Checklist (ASC)
Time frame: Up to 12 Months Post-Activation
Speech recognition testing in the implanted ear(s)
Time frame: Up to 12 Month Post-Activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 SYNCHRONY PIN Cochlear Implant and Cochlear Implant in people with Hearing Loss, Sensorineural, run by Med-El Corporation at 8 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 10 inclusion and 12 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total Score on LittlEARS Auditory Questionnaire (LEAQ) (time frame: Up to 12 Months Post-Activation). The study lists 3 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 15 Oct 2024.