New Bone-Conduction Implant in Clinical Trials
Reinfeldt et al (2015) report on their first six patients implanted with a new direct drive, active, transcutaneous bone-conduction implant (BCI). The BCI device has been developed in cooperation between two research groups in Sweden (Chalmers University of Technology and Sahlgrenska University Hospital).
The BCI is different from other bone conduction (i.e., bone-anchored hearing devices, BHADs) devices in that it is small (12 x 14 x 7 mm), low-profile device and depends on electromagnetic transduction of sound across the skin, thereby not requiring a percutaneous abutment (screw attachment through the skin). The surgery is described as safe and easy with no special surgical tools required.
For clinical evaluation, the authors compared the BCI results to the Ponto Pro Power (Oticon Medical) as the reference device. The results from the first 6 patients indicate 10 to 41 dB improvement from 250 to 8000 Hz, the reference device provided 3 to 31 dB.
The BCI provided an improvement in SRT of 27 dB, the references device provided 23.1 dB. The authors report the APHAB results demonstrated statistically significant improvements in 3 of 4 subscales (EC, BN and RV) and they also report improvements in the Glasgow Benefit Inventory, compared to unaided.
For More Information, References, and Recommendations
Reinfeldt S, Hakansson B, Taghavi H, Jansson K-JF, Eeg-Olofsson M. (2015) The Bone-Conduction Implant—Clinical Results of the First Six Patients. International Journal of Audiology 54:408-416.