Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms

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 setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear implant with FS4T.

Secondary objectives:

Comparison of FS4T and EAFS4T settings

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

  • EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting

    Other intervention

    Comparison of FS4T and EAFS4T

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: EA armOther 1 intervention

Trial outcomes

Primary outcomes

1

Speech recognition in noise

HINT-5 min test. Noise level: 60 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 EAFS4T and with FS4T.

Time frame
6 weeks after EAFS4T fitting

Secondary outcomes

1

Speech recognition in quiet

One list of 10 disyllabic words (Fournier lists) at 65 dB SPL. The participant has to repeat the word emitted. Result: score on 10. Test with EAFS4T and with FS4T

Time frame
6 weeks after EAFS4T fitting
2

Subjective auditory spatial perception

SSQi15 questionnaire (" 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 to 10 ranging from "not at all" to "yes perfectly". 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 EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)

Time frame
at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting
3

Subjective assessment of auditory perception

Assessment of sound quality in silence and in noise with 4 statements. Likert scale from 1 to 5. Score on 20. Likert scale with FS4T (at EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)

Time frame
at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting
4

Subjective assessment of musical perception

Six questions from the Munich Music Self-Questionnaire \[Stark et al. 2003\]. Questionnaire with FS4T (at EAFS4T fitting) and with EAFS4T (6 weeks after EAFS4T fitting)

Time frame
at EAFS4T fitting (6 months after cochlear implant activation) and 6 weeks after EAFS4T fitting

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.