Hearing Loss, Sensorineural
Conditions
Brief 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 hearing aids and aural habilitation.
Interventions
DEVICEMED-EL SYNCHRONY PIN Cochlear Implant
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.
OTHERCochlear Implant
Chart review of subjects implanted with a MED-EL cochlear implant under 6 years of age between January 2005 and October 2020.
Sponsors
Med-El Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
7 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on LittlEARS Auditory Questionnaire (LEAQ) | 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) | 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. | Up to 12 Months Post-Activation | Adverse events will be collected and reported throughout the duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Score on LittlEARS Auditory Questionnaire (LEAQ) | Up to 12 Months Post-Activation | 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. |
| Total Score on Auditory Skills Checklist (ASC) | Up to 12 Months Post-Activation | 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. |
| Speech recognition testing in the implanted ear(s) | Up to 12 Month Post-Activation | Percent change from baseline scores on speech recognition testing with words in quiet and sentences in quiet and noise. |
Countries
United States
Outcome results
None listed