Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Обзор

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.

Вмешательства

• Устройство Default CI fitting
  Programming of cochlear implant speech processor according to standard clinical care
• Устройство Anatomy-based CI fitting
  Programming of cochlear implant speech processor with anatomy-based fitting

Первичные конечные точки

• Speech recognition test in quiet (S0): percentage correctly identified phonemes [Срок оценки: 3 months post-activation]
• Speech recognition test in quiet (S0): percentage correctly identified phonemes [Срок оценки: 6 months post-activation]
• Speech recognition test in quiet (S0): percentage correctly identified phonemes [Срок оценки: 12 months post-activation]
• Speech recognition test in quiet (S0): percentage correctly identified phonemes [Срок оценки: 24 months post-activation]

Вторичные конечные точки (12)

• Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [Срок оценки: 3 months post-activation]
• Speech recognition test in noise (S0N0): the speech reception threshold in dB SNR [Срок оценки: 6 months post-activation]
• Result of the pitch matching test: frequency difference in semitones [Срок оценки: 3 months post-activation]
• Result of the pitch matching test: frequency differences in semitones [Срок оценки: 6 months post-activation]
• Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [Срок оценки: 3 months post-activation]
• Result of the perception of timbre test: Score on Visual Analog Scale (VAS) [Срок оценки: 6 months post-activation]
• Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [Срок оценки: 3 months post-activation]
• Result of the consonance and dissonance rating test: Plot of pleasantness over frequency interval and modulation measure [Срок оценки: 6 months post-activation]
• Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [Срок оценки: 3 months post-activation]
• Result of the speech contrast discrimination test: Psychometric function of phoneme categorization [Срок оценки: 6 months post-activation]
• Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit [Срок оценки: 1 day visit (At the activation of the sound processor)]
• Patient reported outcome- Hearing Implant Sound Quality Index (HISQUI): Total score and classification of self-perceived auditory benefit [Срок оценки: 3 months post-activation]

Критерии участия

Критерии включения

• 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
• Subject implanted with MED-EL cochlear implant(s)
• Subjects received a Flex28, FlexSoft or Standard electrode
• Subject planned to receive a SONNET 2, SONNET 3 or RONDO 3 audio processor on the newly implanted side
• Audio processor not yet activated on the newly implanted side
• The most apical active electrode contact has to be inserted at least 450°
• Minimum of 10 active channels can be activated
• Fluent in the language of the test centre
• Signed and dated Informed Consent Form (ICF) before the start of any study-specific procedure

Критерии исключения

• 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
• Anything that, in the opinion of the Investigator, would place the subject at increased risk or pre-clude the subject's full compliance with or completion of the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 2 центра

• University Hospital Brussels — Brussels
• Antwerp University Hopsital — Antwerp

Идентификаторы

NCT: NCT05451628 · EC-2021-437

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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