Hearing Loss, Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Conditions
Keywords
front-end features, speech perception, patient reported outcome, Cochlear implants, post lingual sensorineural hearing loss
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.
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).
Interventions
DEVICEAudio processor SONNET
AI - N/A, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
DEVICESONNET 2: Configuration 1
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Mild, TNR - Mild
DEVICESONNET 2: Configuration 2
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - Strong, TNR - Strong
DEVICESONNET 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)
DEVICESONNET 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)
DEVICESONNET 2: OPUS 2 configuration
AI - Off, WNR - Off, Beam-former - OMNI, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
DEVICESONNET 2: SONNET configuration
AI - Off, WNR - Mild, Beam-former - NAT, AGC Compression - 3:1, AGC Sensitivity - 75%, ANR - N/A, TNR - N/A
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech in noise | 8 weeks | Oldenburg Sentence Test in noise (S0N0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech in noise | 8 weeks | Oldenburg Sentence Test in noise (S0N0) |
| Quality of hearing | 8 weeks | Hearing Implant Sound Quality Index |
| Device handling | 8 weeks | Audio Processor Satisfaction Questionnaire (APSQ) with a scale range 0 (worst) to 10 (best) |
| Speech in quiet | 8 weeks | Freiburg Monosyllabic test in quiet |
| User Satisfaction | 8 weeks | A product specific questionnaire will be used to gain user satisfaction on the new audio processor and individual setting preferences |
| Device Use | 8 weeks | Data Logging |
| Sound Quality and Quality of hearing | 8 weeks | Hearing Implant Sound Quality Index 19 (HISQUI19) with a 7-point rating scale (never to always) |
| Subjective Ratings | 8 weeks | 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) |
Countries
Germany
Outcome results
None listed