Front-End Processing 3.0

Hearing Loss Clinical Trial

— FEP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861442
• Other study ID #: MED-EL_CRD_2017_06
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 5, 2020

Study information

• Verified date: June 2024
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 5, 2020
• Est. primary completion date: March 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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
• SONNET 2: Configuration 1
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
• SONNET 2: Configuration 2
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
• 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)
• 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)
• 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
• SONNET 2: SONNET configuration
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A

Locations

Country	Name	City	State
Germany	Klinik und Poliklinik für Hals-, Nasen- und Ohrenkrankheiten, plastische und ästhetische Operationen	Würzburg	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Speech in noise	Oldenburg Sentence Test in noise (S0N0)	8 weeks
Secondary	Speech in quiet	Freiburg Monosyllabic test in quiet	8 weeks
Secondary	Speech in noise	Oldenburg Sentence Test in noise (S0N0)	8 weeks
Secondary	Speech in noise	Oldenburg Sentence Test in noise (S0N0T0)	8 weeks
Secondary	Speech in noise	Oldenburg Sentence Test in noise (S0, ±N45, ± N135)	8 weeks
Secondary	Quality of hearing	Hearing Implant Sound Quality Index	8 weeks
Secondary	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)	8 weeks
Secondary	Device handling	Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best)	8 weeks
Secondary	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")	8 weeks
Secondary	Subjective Ratings	Subjective Sound Quality Rating	8 weeks
Secondary	User Satisfaction	A product specific questionnaire will be used to gain user satisfaction on the new audio processor and individual setting preferences	8 weeks
Secondary	Device Use	Data Logging	8 weeks
Secondary	Sound Quality and Quality of hearing	Hearing Implant Sound Quality Index 19 (HISQUI19) with a 7-point rating scale (never to always)	8 weeks

External Links

•   Results of the study, published in an article