Patients under 12 years of age and patients between 12 and 16 years of age who receive a Sentio implant as part of standard care
Conditions
Interventions
Group 1: Arm 1: For patients <12, the implantation (duration of surgery, deviations from standard, complications) of a Sentio implant system from Oticon and the improvement in hearing (pre- and post-o
Sponsors
Klinik für Hals-Nasen-Ohrenheilkunde, Klinik für Kopf- und Hals-Chirurgie
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: Receive Sentio implants as standard care
Exclusion criteria
Exclusion criteria: All patients without a Sentio implant in standard care and patients generally under 2 and over 16 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the feasibility of the operation and hearing improvement through the implant. The feasibility of the operation is evaluated based on duration, deviations from the standard, and complications, while pre- and postoperative tone and speech audiograms are used to assess hearing ability. All of this data is collected as part of routine clinical practice for the treatment of this condition. | — |
Countries
Germany
Outcome results
None listed