Clinical trial NCT04918654: Automatic Sound Management 3.0 in a Single-unit Audio Processor
Official title: Automatic Sound Management 3.0 in a Single-unit Audio Processor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implants
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
Collaborators: name: Hannover Medical School
First posted: 2021-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post-lingually deafened adult cochlear implant users with a MED-EL device.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Speech in noise
timeFrame: Baseline
Secondary outcomes:
measure: Quality of Hearing
timeFrame: Baseline
measure: Device Satisfaction
timeFrame: Baseline
measure: User Satisfaction
timeFrame: Baseline
measure: Speech in noise
timeFrame: Baseline
measure: Speech in noise
timeFrame: Baseline
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: MHH - Medizinische Hochschule Hannover
Study officials:
affiliation: Hals-Nasen-Ohrenklinik der Medizinischen Hochschule Hannover
name: Andreas Büchner, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: