Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization

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 with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without synchronization (ABFnoS) for the accuracy of sound localization.

Secondary objectives:

Comparison of ABFS to ABFnoS for the bias of sound localization. Comparison of ABFS to ABFnoS for speech perception in noise. Comparison of ABFS to ABFnoS 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

Total hearing loss for less than 5 years

Disqualifiers

retro-cochlear pathology: auditory neuropathy, vestibular schwannoma

patient with residual hearing < 70 dB hearing level (HL) at 250 Hz and 500 Hz and < 80 dB HL at 1000 Hz on the contralateral ear

Trial design

Design model

Crossover

Treatments tested in this trial

  • ABFnoS then ABFS (Cochlear implant)

    Device

    Cochlear implant with tonotopy-based fitting without synchronization with the contralateral hearing-aid then with synchronization with the contralateral hearing-aid

  • ABFS then ABFnoS (Cochlear implant)

    Device

    Cochlear implant with tonotopy-based fitting with synchronization with the contralateral hearing-aid then without synchronization with the contralateral hearing-aid

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: ABFnoS then ABFSActive comparator 1 intervention
Group B: ABFS then ABFnoSActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of sound localization

The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Time frame
at 6 weeks post-activation
2

Accuracy of sound localization

The accuracy of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Time frame
at 12 weeks post-activation

Secondary outcomes

1

Bias of sound localization

The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Time frame
at 6 weeks post-activation
2

Bias of sound localization

The bias of sound localization will be achieved with a sound localization test in the horizontal plane with 7 loudspeakers (HP) spaced 30° apart and arranged in a ½ circle from -90° to +90° at 1m around the patient.

Time frame
at 12 weeks post-activation
3

Speech recognition in noise

The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test \[Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis . 2018 Oct;135(5):315-319.\]. It is a sentence test with target words. The speech level is at 65 dB sound pressure level (SPL) and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.

Time frame
at 6 weeks post-activation
4

Speech recognition in noise

The speech recognition in noise is evaluated with the French-language VRB (vocale rapide dans le bruit) test \[Leclerc et al., Eur Ann Otorhinolaryngol Head Neck Dis . 2018 Oct;135(5):315-319.\]. It is a sentence test with target words. The speech level is at 65 dB SPL and the signal-to-noise ratio varies from 18 dB to -3 dB by 3 dB step.

Time frame
at 12 weeks post-activation

Other outcomes

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