Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMED-EL Elektromedizinische Geräte GesmbH

About this trial

Main objective:

Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.

Secondary objectives:

Comparison of FS4noT and FS4T settings

* for speech recognition in quiet * for subjective auditory spatial perception

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patient (>= 18 years old) speaking French

Patient who fulfils the criteria for cochlear implantation

Disqualifiers

retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

Trial design

Design model

Single group

Treatments tested in this trial

  • Tonotopic cochlear implant fitting FS4T

    Other intervention

    Comparison of FS4T and FS4noT

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: ABF armOther 1 intervention

Trial outcomes

Primary outcomes

1

Speech recognition in noise

Framatrix test. Speech and noise in front the participant (at 1m). Noise level: 65 dB SPL. Speech level: adaptive with the answers of the participant. Result: speech-to-noise ratio (speech reception threshold, SRT50) for 50% of intelligibility in noise. Test with FS4T and with FS4noT

Time frame
6 weeks after FS4T fitting

Secondary outcomes

1

Speech recognition in quiet

Two lists of 10 disyllabic words (Fournier lists) at 65 dB SPL. The participant has to repeat the word emitted. Result: score on 20. Test with FS4T and with FS4noT.

Time frame
6 weeks after FS4T fitting
2

Subjective auditory spatial perception

Questionnaire SSQi15 (" Speech, Spatial, and Qualities of hearing scale ", SSQ). The questionnaire consists of 15 questions describing various real-world hearing situations. The subject answers each question with a score on a visual analogue scale graduated from 0 (worse) to 10 (better) ranging from "not at all" (0) to "yes perfectly" (10). The result obtained is composed of * a total average score equal to the sum of the scores of all the questions divided by the total number of questions. * 3 average sub-scores describing 3 subscales: Speech hearing with 5 questions Spatial hearing with 5 questions Quality of hearing with 5 questions. Questionnaire with FS4T (at FS4T fitting) and with FS4noT (6 weeks after FS4T fitting)

Time frame
At FS4T fitting and 6 weeks after FS4T fitting

Other outcomes

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