Front-End Processing 3.0

NCT03861442 | Completed

• 1 other identifier: MED-EL_CRD_2017_06
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Speech in noise

  Oldenburg Sentence Test in noise (S0N0)

  8 weeks

Secondary Outcomes (12)

• Speech in quiet

  8 weeks

• Speech in noise

  8 weeks

• Speech in noise

  8 weeks

• Speech in noise

  8 weeks

• Quality of hearing

  8 weeks

Study Arms (1)

Subjects

Adult unilateral MED-EL Cochlear implant users (≥ 6 months), with post-lingual, severe to profound sensory-neural hearing loss.

Device: Audio processor SONNET; Device: SONNET 2: Configuration 1; Device: SONNET 2: Configuration 2; Device: SONNET 2: Configuration 3; Device: SONNET 2: Configuration 4; Device: SONNET 2: OPUS 2 configuration; Device: SONNET 2: SONNET configuration

Interventions

Audio processor SONNET DEVICE

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

Also known as: Default

Subjects

SONNET 2: Configuration 1 DEVICE

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

Subjects

SONNET 2: Configuration 2 DEVICE

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

Subjects

SONNET 2: Configuration 3 DEVICE

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

Subjects

SONNET 2: Configuration 4 DEVICE

AI - Strong, WNR - Strong, Beam-former - Auto (OMNI-ABF), AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Auto (Off-Strong), TNR - Auto (Off-Strong)

Subjects

SONNET 2: OPUS 2 configuration DEVICE

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

Subjects

SONNET 2: SONNET configuration DEVICE

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

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-lingually deafened adult cochlear implant users with a MED-EL device

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

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

Würzburg, Bavaria, 97080, Germany

Location

Related 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.

  PMID: 36108069 RESULT

Related Links

• Results of the study, published in an article

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Bilateral

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2019
• First Posted: March 4, 2019
• Study Start: April 1, 2019
• Primary Completion: March 5, 2020
• Study Completion: March 5, 2020
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)