Automatic Sound Management 3.0 in a Single-unit Audio Processor

NCT04918654 | Completed

• 1 other identifier: RND3_MED-EL_CRD_2020_03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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-Noise reduction, Ambient noise reduction, Transient noise reduction, Adaptive intelligence).

Conditions

Cochlear Implants

Outcome Measures

Primary Outcomes (1)

• Speech in noise

  Oldenburg Sentence Test in noise (S0 N±90 N180)

  Baseline

Secondary Outcomes (5)

• Quality of Hearing

  Baseline

• Device Satisfaction

  Baseline

• User Satisfaction

  Baseline

• Speech in noise

  Baseline

• Speech in noise

  Baseline

Study Arms (1)

Study Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-lingually deafened adult cochlear implant users with a MED-EL device.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead
• Hannover Medical School: collaborator

Study Sites (1)

MHH - Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Related Publications (1)

• Buchner A, Rottmann T, Lenarz T, Lesinski-Schiedat A, Aschbacher E, Fruhauf F, Bracker T, Billinger-Finke M. Clinical improvement of speech perception in noise with Automatic Sound Management 3.0. Hear Res. 2025 Dec;468:109445. doi: 10.1016/j.heares.2025.109445. Epub 2025 Oct 4.

  PMID: 41115327 RESULT

Study Officials

• Andreas Büchner, Prof. Dr.

  Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 9, 2021
• Study Start: June 25, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

DE (1)