Status:
COMPLETED
Automatic Sound Management 3.0 in a Single-unit Audio Processor
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Collaborating Sponsors:
Hannover Medical School
Conditions:
Cochlear Implants
Eligibility:
All Genders
18+ years
Brief Summary
Cochlear implants are routine treatment for people with severe hearing loss. This study tests the RONDO 3, MED-EL's newest single-unit audio processor which comes with new features (Beamformer, Wind-N...
Detailed Description
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit fr...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- A minimum of 18 years old
- Experienced user of a RONDO 3 (≥ 3 months) for the ear to be tested
- Post-lingual onset of severe to profound sensory-neural hearing loss on the ear to be tested
- A minimum of 40% speech recognition in the Freiburg Monosyllables Test in quiet at 65 dB SPL for the ear to be tested (at the last time tested in clinical routine)
- Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure.
- Exclusion criteria
- Lack of compliance with any inclusion criteria
- CI user with contralateral hearing equal to or better than 30 dB (pure-tone average over the following frequencies: 250, 500, 1000, and 2000 Hz)
- Implanted with C40X, or C40C on the ear to be tested
- Implanted with an Auditory Brainstem Implant (ABI) or split electrode array
- Known allergic reactions to components of the investigational medical device (RONDO 3) or the SONNET 2
- Anything that, in the opinion of the Investigator, would (a) place the subject at increased risk, (b) preclude the subject's full compliance with or completion of the study
Exclusion
Key Trial Info
Start Date :
June 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04918654
Start Date
June 25 2021
End Date
December 11 2023
Last Update
November 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
MHH - Medizinische Hochschule Hannover
Hanover, Germany, 30625