Evaluation of a new procedure to optimize ESRT measurements
- Conditions
- H90.8Mixed conductive and sensorineural hearing loss, unspecified
- Registration Number
- DRKS00024716
- Lead Sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Age = 18 months
- Patients unilaterally or bilaterally implanted with a MED-EL CI for at least 6 months
- Measurable electrically-evoked stapedius reflexes on at least one side
- Patients younger than 9 years old can be included in the study even if for technical reasons (Leakage) the screening cannot be performed successfully.
- Lack of compliance with any inclusion criteria
- Pregnant or breast-feeding women
- Any clinical conditions that might result in alteration of the outcomes of this clinical investigation
- Use of an active medical implant in addition to the CI (e.g. heart pacemaker)
- Known allergies or intolerance to medical grade silicone or any other material used for the experiments described in this protocol
- Parallel participation in a device/drug clinical investigation in the period of data collection, which could confound the results of the experiments described in this protocol
- Anything that, in the opinion of the Audiologist, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of the experiments described in this protocol
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this clinical investigation is to determine whether the ESR threshold levels achieved with the ESRT protocol correlate with the MCL values obtained by means of the behavioral fitting procedure selected at the recruiting site, based on the evaluated patient’s age.
- Secondary Outcome Measures
Name Time Method This clinical investigation has no secondary objectives.