Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting

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

About this trial

Main objective:

For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.

Secondary objectives:

Comparison of TFS4 to FS4 for speech recognition in quiet. Comparison of TFS4 to FS4 for the auditory skills experienced by the subject.

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

patient with residual hearing < 70 dB hearing level (HL) at 500 Hz and 1000 Hz on the contralateral ear

Trial design

Design model

Crossover

Treatments tested in this trial

  • FS4 then TFS4 (cochlear implant)

    Device

    Cochlear implant with default fitting then with tonotopy-based fitting

  • TFS4 then FS4 (cochlear implant)

    Device

    Cochlear implant with tonotopy-based fitting then with default fitting

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: FS4 then TFS4Active comparator 1 intervention
Group B: TFS4 then FS4Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Speech recognition in noise

The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].

Time frame
at 6 weeks post-activation
2

Speech recognition in noise

The speech recognition in noise is evaluated with the French Matrix test (Framatrix) \[S. Jansen et al. Comparison of three types of French speech-in-noise tests: a multi-center study. Int J Audiol, 51 (3) (2012), pp. 164-173\].

Time frame
at 12 weeks post-activation

Secondary outcomes

1

Speech recognition in quiet

Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.

Time frame
at 6 weeks post-activation
2

Speech recognition in quiet

Cochlear list of Lafon: list of 51 phonems (17 words). Speech recognition score on 50.

Time frame
at 12 weeks post-activation
3

Auditory skills experienced by the patient

Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations \[Moulin et al. Ear \& Hearing 2019;40;938-950\].

Time frame
at 6 weeks post-activation
4

Auditory skills experienced by the patient

Auditory skills experienced by the patient are evaluated with the short form of the French version of the speech spatial qualities scale (SSQ) with of 15 questions describing various real-world auditory situations \[Moulin et al. Ear \& Hearing 2019;40;938-950\].

Time frame
at 12 weeks post-activation

Other outcomes

Sponsors and contacts

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