Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. At present, most CI recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. In this study, a fitting strategy based on the post-operative CT scan, that will allow the audiologist to set a frequency-band distribution for CI fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s)

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

Pre-operative result of pure-tone audiometry, speech test in quiet and in noise available

Disqualifiers

Lack of compliance with any inclusion criteria

Electric Acoustic Stimulation (EAS) user (user of an EAS audio processor)

Implanted with C40+, C40X and C40C

Implanted with an Auditory Brainstem Implant (ABI) or Split electrode array

Trial design

Design model

Parallel

Treatments tested in this trial

  • Default CI fitting

    Device

    Programming of cochlear implant speech processor according to standard clinical care

  • Anatomy-based CI fitting

    Device

    Programming of cochlear implant speech processor with anatomy-based fitting

Treatment groups

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

Trial outcomes

Primary outcomes

1

Speech recognition test in quiet (S0): percentage correctly identified phonemes

Time frame
3 months post-activation
2

Speech recognition test in quiet (S0): percentage correctly identified phonemes

Time frame
6 months post-activation
3

Speech recognition test in quiet (S0): percentage correctly identified phonemes

Time frame
12 months post-activation
4

Speech recognition test in quiet (S0): percentage correctly identified phonemes

Time frame
24 months post-activation

Secondary outcomes

1

Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

Time frame
3 months post-activation
2

Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR

Time frame
6 months post-activation
3

Result of the pitch matching test: frequency difference in semitones

Time frame
3 months post-activation
4

Result of the pitch matching test: frequency differences in semitones

Time frame
6 months post-activation

Other outcomes

Sponsors and contacts

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

Universitair Ziekenhuis Brussel

Lead sponsor

University Hospital, Antwerp

Collaborator