Clinical trial NCT03861442: Front-End Processing 3.0
Official title: Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Keywords: front-end features
speech perception
patient reported outcome
Cochlear implants
post lingual sensorineural hearing loss
Lead sponsor: MED-EL Elektromedizinische Geräte GesmbH
Sponsor class: INDUSTRY
First posted: 2019-03-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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: This study investigated the impact of Automatic Sound Management 3.0 (i.e. ambient noise reduction, transient noise reduction and an adaptive intelligence) as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing and device handling.

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 new SONNET2 audio processor, ASM 3.0 was implemented and the features ambient noise reduction, transient noise reduction and an adaptive intelligence (AI) were added.

This study investigated the impact of ASM 3.0 as implemented in the SONNET2 on CI users' speech performance and their subjective quality of hearing.

Subjects' speech performance was tested in quiet (Freiburg Monosyllables Test) and noise (OLSA) with the SONNET audio processor and the SONNNET 2 audio processor (OPUS 2 Configuration, SONNET Configuration, SONNET 2 Configurations 1-4). Additionally, quality of hearing with two questionnaires (HISQUI19, SSQ12) was evaluated with the subjects SONNET and the SONNET 2 configurations 1-4. Device handling with the SONNET and the SONNET 2 audio processor was investigated with a questionnaire (APSQ). Additionally, the data logging function of the SONNET2 audio processor was used to investigate differences in the use of the SONNET configuration and the SONNET 2 configurations 1-4. Subjects were asked to rate the SONNET 2 configurations 1-4 against the SONNET configuration with a product-specific SONNET2 questionnaires. Further, subjective sound quality was evaluated in different auditory settings and subjects' subjective listening effort was evaluated using the ACAES test with the SONNET 2 (OPUS configuration, SONNET configuration, SONNET 2 configuration 1\&2).

Eligibility criteria: Inclusion Criteria:

* A minimum of 18 years old
* Experienced user (≥ 6 months) of a MED-EL cochlear implant (CI; C40+ and later model)
* Experienced user of a MED-EL SONNET audio processor (≥ 6 months)
* Post-lingual onset of bilateral severe to profound sensory-neural hearing loss
* Unilateral CI user
* A minimum of 10 active electrodes
* A minimum of 40% speech recognition in the Freiburg Monosyllables test in quiet at 65 dB sound pressure level (SPL; at the last time tested)
* Fluent in German (the language of the test centre)
* Signed and dated Informed Consent Form 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 60 dB (PTA measured at 500, 1000, and 2000Hz)
* User with electric-acoustic stimulation (EAS; user of an EAS audio processor)
* Implanted with C40X and C40C
* Implanted with an Auditory Brainstem Implant or Split electrode array
* Known allergic reactions to components of the investigational medical device
* Unstable psychological status
* Anything that, in the opinion of the Investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study

Primary outcomes:
measure: Speech in noise
timeFrame: 8 weeks
Secondary outcomes:
measure: Speech in quiet
timeFrame: 8 weeks
measure: Speech in noise
timeFrame: 8 weeks
measure: Speech in noise
timeFrame: 8 weeks
measure: Speech in noise
timeFrame: 8 weeks
measure: Quality of hearing
timeFrame: 8 weeks
measure: Quality of hearing
timeFrame: 8 weeks
measure: Device handling
timeFrame: 8 weeks
measure: Subjective Ratings
timeFrame: 8 weeks
measure: Subjective Ratings
timeFrame: 8 weeks
measure: User Satisfaction
timeFrame: 8 weeks
measure: Device Use
timeFrame: 8 weeks
measure: Sound Quality and Quality of hearing
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen
state: Bayern
Study officials:
References:
citation: Kurz A, Rak K, Hagen R. Improved performance with automatic sound management 3 in the MED-EL SONNET 2 cochlear implant audio processor. PLoS One. 2022 Sep 15;17(9):e0274446. doi: 10.1371/journal.pone.0274446. eCollection 2022.