Cochlear ImplantsRND3NCT04918654
Automatic Sound Management 3.0 in a Single-unit Audio Processor
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cochlear Implants
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jun 2021to 11 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Post-lingually deafened adult cochlear implant users with a MED-EL device.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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 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.
- Conditions
- Cochlear Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech in noise
Oldenburg Sentence Test in noise (S0 N±90 N180)
Measured: Baseline
Secondary outcomes (5)
Quality of Hearing
Hearing Implant Sound Quality Index (HISQUI). Min score: 16, Max score 133. Higher scores mean a better outcome.
Measured: Baseline
Device Satisfaction
Audio Processor Satisfaction Questionnaire. Min score: 0, Max score 10. Higher scores mean a better outcome.
Measured: Baseline
User Satisfaction
Product-specific questionnaire. The questionnaire is not reporting a single score on a scale (min/max score not applicable).
Measured: Baseline
Speech in noise
Oldenburg Sentence Test in noise (S0 N±90 N180)
Measured: Baseline
Speech in noise
Oldenburg Sentence Test in noise (S0 N0)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start25 Jun 2021
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cochlear ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School
- Responsible party
- Sponsor
- Investigators
- Andreas Büchner, Prof. Dr., Principal investigator, Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918654
- Sponsor's protocol ID
- RND3_MED-EL_CRD_2020_03
- Acronym
- RND3
- Status last verified
- Nov 2025
- First submitted
- 31 May 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41115327
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automatic Sound Management 3.0 in a Single-unit Audio Processor
- ClinicalTrials.gov ID
- NCT04918654
- Acronym / sponsor ID
- RND3 / RND3_MED-EL_CRD_2020_03
- Conditions
- Cochlear Implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Hannover Medical School
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post-lingually deafened adult cochlear implant users with a MED-EL device.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Speech in noise
Time frame: Baseline
Oldenburg Sentence Test in noise (S0 N±90 N180)
5 secondary outcomes
Quality of Hearing
Time frame: Baseline
Device Satisfaction
Time frame: Baseline
User Satisfaction
Time frame: Baseline
Speech in noise
Time frame: Baseline
Speech in noise
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Results publication: PubMed 41115327Buchner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Büchner, Prof. Dr. principal investigator
Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cochlear Implants, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech in noise (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.