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Recruiting NCT07294976

Evaluation of Actual Maximum Gain in Bone Anchored Devices

No phase Interventional Mixed Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone Anchored Device A, Bone Anchored Device B, Bone Anchored Device C.
Who it may be relevant to
Registry conditions: Mixed Hearing Loss. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • 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 [Time frame: Baseline, at fitting]
Secondary outcome measures (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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, at fitting]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

Sweden · 1 center
  • Göteborgs Universitet — Gothenburg

Identifiers

NCT: NCT07294976 · BC126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗