H90.3 H90.4
Conditions
Interventions
Group 1: binaural provision with Vibrosonic alpha
Sponsors
Vibrosonic GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: IC1: Ability of subject to understand character and individual consequences of the study IC2: Written informed consent and privacy statement IC3: Age =18 IC4: Patient receiving the device after study initiation OR (Patient has received the device before study initiation AND sufficient documentation of required data points is available in medical records and collected not before 2025/03)* *Explanation of IC4: Patients who have already received the device before study initiation may be included retrospectively, provided that informed consent is obtained, and sufficient documentation of baseline and follow-up data is available in their medical records.
Exclusion criteria
Exclusion criteria: EC1: Held in an institution by legal or official order EC2: Insufficient German language proficiency to complete the Freiburg Speech Perception Test (Freiburger Sprachverständlichkeitstest), defined as inadequate knowledge of common German words used in the test material.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Generate comprehensive long-term data in real-world settings on tolerability - Generate comprehensive long-term data in real-world settings on performance stability | — |
Secondary
| Measure | Time frame |
|---|---|
| - Detect potential side effects through expanded population monitoring - Evaluate speech recognition improvements in a real-world patient population - Assess user satisfaction and audiological outcomes in routine clinical practice | — |
Countries
Germany
Contacts
Public ContactHelen Heinermann
Vibrosonic GmbH
Outcome results
None listed