NCT03861442

Front-End Processing 3.0

Front-End Processing 3.0 - Noise Reduction, Transient Reduction, Scene Classifier

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: MED-EL Elektromedizinische Geräte GesmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Bilateral

Interventions

Type	Name	Description
DEVICE	Audio processor SONNET	AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
DEVICE	SONNET 2: Configuration 1	AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
DEVICE	SONNET 2: Configuration 2	AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
DEVICE	SONNET 2: Configuration 3	AI - Mild, WNR - Mild, Beam-former - Auto (NAT), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Mild), TNR - Auto (Off-Mild)
DEVICE	SONNET 2: Configuration 4	AI - Strong, WNR - Strong, Beam-former - Auto (OMNI-ABF), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Strong), TNR - Auto (Off-Strong)
DEVICE	SONNET 2: OPUS 2 configuration	AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
DEVICE	SONNET 2: SONNET configuration	AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-03-05
• Completion: 2020-03-05
• First posted: 2019-03-04
• Last updated: 2024-06-05

Locations

1 site across 1 country: Germany