Front-End Processing 3.0

MED-EL Elektromedizinische Geräte GesmbH20 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hearing Loss Hearing Loss, Sensorineural Hearing Loss, Bilateral

Interventions

Audio processor SONNETDEVICE

AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

SONNET 2: Configuration 1DEVICE

AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild

SONNET 2: Configuration 2DEVICE

AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen

Würzburg, Bavaria, Germany

Outcomes

Primary Outcomes

Speech in noise

Oldenburg Sentence Test in noise (S0N0)

Time frame: 8 weeks

Secondary Outcomes

Speech in quiet

Freiburg Monosyllabic test in quiet

Time frame: 8 weeks

Speech in noise

Oldenburg Sentence Test in noise (S0N0)

Time frame: 8 weeks

Speech in noise

Oldenburg Sentence Test in noise (S0N0T0)

Time frame: 8 weeks

Speech in noise

Oldenburg Sentence Test in noise (S0, ±N45, ± N135)

Time frame: 8 weeks

Quality of hearing

Hearing Implant Sound Quality Index

Time frame: 8 weeks

Quality of hearing

Questionnaire: The Speech, Spatial and Qualities of Hearing Scale (SSQ12; short version, 12 items) with a scale range 0 (worst) to 10 (best)

Time frame: 8 weeks

Device handling

Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best)

Time frame: 8 weeks

Subjective Ratings

Adaptive CAtegorical Listening Effort Scaling (ACALES); Subjectively perceived listening Effort is evaluated using a 14-step scale contains eight labelled categories (from "effortless" to "extremely strenuous" and "noise only")

Data from ClinicalTrials.gov

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