N/A
Completed N=30
A Comparative, Controlled, Clinical Investigation and Quality Control of a New Hearing Aid
Source: ClinicalTrials.gov NCT03086018 ↗Enrolled (actual)
30
Serious AEs
3.3%
Results posted
Nov 2019
Primary outcomePrimary: Speech Intelligibility Performance — -1.25; -3.89; -5.22 dB SNR
Summary
The aim of this study is to investigate the performance of the hearing aid under laboratory as well as everyday conditions. In addition, the performance data of the hearing aid are compared with a Bernafon hearing aid already available on the market.
The hearing aids are adapted according to the user requirements. The data collected in the study is intended to show that the benefit of the hearing aid being examined is identical or better than the current CE-marked hearing aid. A further aim is to improve the adaptation of the hearing device in such a way that the benefit for people with hearing impairments can be increased.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Intelligibility Performance |
-1.25; -3.89; -5.22 | — |
| SECONDARY Subjective Performance of Aided Benefit |
37.38; 44.29; 42.08; -17.63; 40.30 | — |
| SECONDARY Speech Intelligibility Performance With New Feature |
73.5; 73.7; 87.27; 88.1 | — |
| SECONDARY Handling/Usability Performance |
97 | — |
| SECONDARY Events |
4 | — |
Eligibility Criteria
Inclusion Criteria
- All classifications of hearing loss (sensorineural, conductive, mixed)
- If the hearing loss is conductive or mixed it must be approved for amplification by a physician
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to severe
- German speaking
- Ability and willingness to sign the consent form
Exclusion Criteria
- Contraindications for amplification
- Active ear disease
- Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant,
- A reduced mobility making them unable to attend weekly study appointments
- A reduced ability to describe auditory impressions and the usage of the hearing aids
- Uncooperative so that it is not possible to record a valid pure tone audiogram
- A strongly reduced dexterity
- Central hearing disorders
- Bernafon employees
- Family members of Bernafon employees
Data sourced from ClinicalTrials.gov (NCT03086018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.