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Procedure
Single-arm for Sensorineural Hearing Loss
N/A
Waitlist Available
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to twelve (12) months post-activation
Awards & highlights
Study Summary
This trial is testing whether a MED-EL cochlear implant can help adults with moderate to profound sensorineural hearing loss who don't get much benefit from hearing aids.
Eligible Conditions
- Sensorineural Hearing Loss
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to twelve (12 months) post-activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to twelve (12 months) post-activation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ear structure
Percent correct words recognition in quiet in implanted ear
Secondary outcome measures
Number and proportion of subjects experiencing device related adverse events
Patient reported improvement in everyday listening conditions
Residual low frequency hearing
Trial Design
1Treatment groups
Experimental Treatment
Group I: Single-armExperimental Treatment1 Intervention
Single-arm, repeated-measures study design with all subjects receiving a MED-EL cochlear implant
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System
2018
N/A
~50
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Who is running the clinical trial?
Med-El CorporationLead Sponsor
23 Previous Clinical Trials
969 Total Patients Enrolled
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