Front-End Processing 3.0

Study Overview
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Brief Summary
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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. With the new SONNET 2 audio processor, ASM 3.0 was implemented and the features noise reduction, transient reduction and an automatic scene classifier were added. This study will investigate the impact of ASM 3.0 as implemented in the SONNET 2 on CI users' speech performance and their subjective quality of hearing.

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

Conditions
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Cochlear Implants

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech in noise | Oldenburg Sentence Test in noise (S0N0) | 8 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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front-end features, speech perception, patient reported outcome