Front-End Processing 3.0 (FEP3)

MED-EL

Status

Completed

Conditions

Hearing Loss

Hearing Loss, Bilateral

Hearing Loss, Sensorineural

Treatments

Device: SONNET 2: Configuration 3

Device: SONNET 2: OPUS 2 configuration

Device: SONNET 2: Configuration 2

Device: Audio processor SONNET

Device: SONNET 2: Configuration 4

Device: SONNET 2: SONNET configuration

Device: SONNET 2: Configuration 1

Study type

Observational

Funder types

Industry

Identifiers

NCT03861442

MED-EL_CRD_2017_06

Details and patient eligibility

About

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.

Full 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).

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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