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Completed

NCT Number: NCT04918654

Automatic Sound Management 3.0 in a Single-unit Audio Processor

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).

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Key information

Conditions

Cochlear Implants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MHH - Medizinische Hochschule Hannover

Hanover, 30625, Germany

About this study

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 from acoustic amplification in the best aided condition. Front-end processing of acoustic signals picked up by the audio processor is routinely applied to provide optimal hearing performance under varying listening conditions. Automatic Sound Management (ASM) was introduced by MED-EL with the TEMPO+ audio processor and provided advanced compression and automatic gain management. With the SONNET audio processor, MED-EL introduced ASM 2.0, which added wind noise reduction and microphone directionality to the front-end processing. With the SONNET 2 audio processor, ASM 3.0 was implemented and the features ambient noise reduction, transient noise reduction and an adaptive intelligence (AI) were added. The RONDO 3 implements now ASM 3.0.

This study investigates the impact of ASM 3.0 as implemented in the RONDO 3 on CI users' speech performance and their subjective quality of hearing.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Speech in noise

    Time frame: Baseline

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

Secondary outcomes

  1. Quality of Hearing

    Time frame: Baseline

    Hearing Implant Sound Quality Index (HISQUI). Min score: 16, Max score 133. Higher scores mean a better outcome.

  2. Device Satisfaction

    Time frame: Baseline

    Audio Processor Satisfaction Questionnaire. Min score: 0, Max score 10. Higher scores mean a better outcome.

  3. User Satisfaction

    Time frame: Baseline

    Product-specific questionnaire. The questionnaire is not reporting a single score on a scale (min/max score not applicable).

  4. Speech in noise

    Time frame: Baseline

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

  5. Speech in noise

    Time frame: Baseline

    Oldenburg Sentence Test in noise (S0 N0)

Sponsors and collaborators

Lead sponsor

MED-EL Elektromedizinische Geräte GesmbH

Industry

Collaborators

  • Hannover Medical School

Registry information

Acronym: RND3

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 9, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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