Introduction: The bone conduction implant (BCI), is a new active transcutaneous hearing implant with a transducer surgically implanted under intact skin.
We present the surgical procedure and the results so far of a multicentre clinical trial of this novel device.
Patients and Methods: 11 patients aged 18–67 years at 2 academic university hospitals in Sweden have been recruited and implanted with the BCI.
All patients have a mild to moderate conductive or mixed hearing loss and underwent audiometric assessment as well as completed abbreviated profile of hearing aid benefit (APHAB) and Glasgow benefit inventory (GBI) questionnaires. Results presented here are from the 6 month follow up the first 6 patients. As a reference device, a Ponto Pro Power (Oticon Medical) was used on a softband for a month prior to surgery.
All patients then underwent placement of the BCI device under general anaesthesia. The device was switched on at 1 month post surgery and audiometric assessment was repeated.
Results: The surgical procedure was uneventful with no immediate adverse events.
The BCI had a statistically significant improvement over the unaided condition with a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation.
Conclusion: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.
