Evaluation of Actual Maximum Gain in Bone Anchored Devices

Обзор

This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users. Bone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals. In this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.

Вмешательства

• Устройство Bone Anchored Device A
  Fitting Device A
• Устройство Bone Anchored Device B
  Fitting Device B
• Устройство Bone Anchored Device C
  Fitting Device C

Первичные конечные точки

• Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000 [Срок оценки: Baseline, at fitting]

Вторичные конечные точки (6)

• Difference in actual maximum gain in dB, between Device A compared to Device B for the for the mean average of the frequencies 500, 1000, 2000 and 4000 [Срок оценки: Baseline, at fitting]
• Difference in actual maximum gain in dB, between Device A compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz [Срок оценки: Baseline, at fitting]
• Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000 [Срок оценки: Baseline, at fitting]
• Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000 and 4000 [Срок оценки: Baseline, at fitting]
• Difference in actual maximum gain in dB, between Device C compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz [Срок оценки: Baseline, at fitting]
• Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C [Срок оценки: Baseline, at fitting]

Критерии участия

Критерии включения

• BAHS user with an Oticon Medical compatible abutment
• Signed Informed Consent Form
• Adult, 18 years or older
• MHL with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of 25-65dB HL on the indicated ear
• MHL with an air-bone-gap (difference between BC and AC thresholds) of at least 15 dB measured at 0.5, 1, 2 and 3 kHz
• At least 3 months of experience using a bone conduction device.
• Fluent in Swedish to be able to read and understand patient information and informed consent process

Критерии исключения

• Participation in another clinical investigation which might cause interference with study participation.
• Subjects who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Швеция · 1 центр

• Göteborgs Universitet — Gothenburg

Идентификаторы

NCT: NCT07294976 · BC126

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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