H90.8
Conditions
Interventions
Group 1: The aim of this clinical trial is to evaluate a new method for ESRT measurement that, compared to the standard method, does not involve pressure equalization between the ear canal and middle
Sponsors
MED-EL Elektromedizinische Geräte GmbH
Eligibility
Sex/Gender
All
Age
18 Months to No maximum
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| This clinical investigation has no secondary objectives. | — |
Countries
Austria, Germany
Contacts
Public ContactPia Plattner
MED-EL Elektromedizinische Geräte GmbH
Outcome results
None listed