The Effect of Anatomy-based Fitting on the Perception of Speech in Noise and Music in Single-sided Deaf Cochlear Implant Users

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

The present study evaluates the effect of anatomy-based fitting on speech perception in noise and music perception in newly implanted single-sided deaf (SSD) CI recipients. Speech perception in noise will be assessed using different spatial configurations of speech and noise. Music perception will be evaluated using objective measurements for melody, harmony, timbre and pitch and using a subjective questionnaire, the Music and Cochlear implant questionnaire (MCIQ). Furthermore, localization and self-reported hearing benefit (HISQUI19, SSQ12) will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Post-lingual onset of unilateral severe-to-profound sensorineural hearing loss

Contralateral hearing < 30 dB HL (PTA measured at 500Hz, 1kHz, 2kHz en 4 kHz)

Post-operative Computed Tomography (CT) scan of the CI elec-trode available

Disqualifiers

Lack of compliance with any inclusion criteria

Implanted with C40+, C40X and C40C

Implanted with an ABI or Split electrode array

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anatomy-based fitting

    Device

    Anatomy-based programming of the speech processor of the cochlear implant

  • Default fitting

    Device

    Default programming of the speech processor of the cochlear implant according to standard clinical practice

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Anatomy-based fittingActive comparator 1 intervention
Group B: Default fittingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Speech perception in noise

Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant

Time frame
3 months post-activation of the audioprocessor
2

Speech perception in noise

Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant

Time frame
6 months post-activation of the audioprocessor
3

Speech perception in noise

Speech reception threshold in dB SNR for the following spatial configurations: S0N0, S0NSSD and SSSDNNH, measured with and without the cochlear implant

Time frame
12 months post-activation of the audioprocessor

Secondary outcomes

1

Pitch ranking

Frequency difference in semitones between CI and NH

Time frame
3 months post-activation
2

Pitch ranking

Frequency difference in semitones between CI and NH

Time frame
6 months post-activation
3

Pitch ranking

Frequency difference in semitones between CI and NH

Time frame
12 months post-activation
4

Perception of timbre

Score on Visual Analog Scale (VAS). Patients have to rate the timbre on a visual analog scale (VAS) ranging from 0 to 10, with a score of 5 indicating a similar timbre between CI and NH.

Time frame
3 months post-activation

Other outcomes

Sponsors and contacts

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