Front-End Processing 3.0

Cochlear Implants 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: September 2021
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

• Cochlear Implants

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, 

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