Evaluation of Actual Maximum Gain in Bone Anchored Devices

Oticon Medical20 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Mixed Hearing Loss

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. BAHS user with an Oticon Medical compatible abutment 2. Signed Informed Consent Form 3. Adult, 18 years or older 4. 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 5. 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 6. At least 3 months of experience using a bone conduction device. 7. Fluent in Swedish to be able to read and understand patient information and informed consent process Exclusion Criteria: 1. Participation in another clinical investigation which might cause interference with study participation. 2. 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.

Outcomes

Primary Outcomes

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