Conductive Hearing Loss, Mixed Hearing Loss
Conditions
Keywords
Bone conduction hearing devices, conductive hearing loss, mixed hearing loss, bone conduction
Brief summary
This study will investigate the performance of four non-surgical bone conduction devices.
Interventions
OTHERBone conduction devices
Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D
Sponsors
Oticon Medical
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed Informed Consent Form 2. Adults (from 18 to 84 years) 3. Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears 4. 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. Participants who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in aided thresholds between device A and device B for PTA4. | Baseline, at fitting | PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in aided thresholds between device A and device D for PTA4. | Baseline, at fitting | PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. |
| Difference in aided thresholds between device A and device C for PTA4. | Baseline, at fitting | PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz. |
Countries
Sweden
Contacts
CONTACTLouise Waldenby
Outcome results
None listed