Early Osia® 2 bone conduction hearing implant experience: Nationwide controlled-market release data and single-center outcomes.

PURPOSE: Bone conduction hearing devices are a well-established treatment option for conductive or mixed hearing losses as well as single-sided deafness. The Osia® 2 System is an active osseointegrated device where a surgically implanted titanium fixture supports a newly developed piezoelectric actuator that is placed under the skin.

METHODS

Nationwide data collected during a controlled-market release (CMR) of the Cochlear™ Osia® 2 System as well as outcomes at single, tertiary-level private practice Otology/Neurotology center were retrospectively reviewed. Key learnings from surgeons and audiologists are discussed.

RESULTS

During the CMR period, 23 surgeons performed 44 operations on 43 recipients. The mean age of recipients was 44 years and mean surgery duration was 52 min. The most commonly used incision was postauricular but anterior to the device (78%). Five complications were observed during the CMR, none of which were device related. Twenty-one audiologists performed 33 Osia® 2 activations during the CMR. The mean age of this group was 47 years, and the mean duration of each activation appointment was 55 min. Single-center data at the authors' institution demonstrated an average additional PTA4 gain with the Osia® 2 patients of 9.6 dB compared to Baha Attract and 10.2 dB compared to Baha Connect.

CONCLUSION

The Cochlear™ Osia® 2 System represents a significant advance in auditory osseointegrated implant technology. Digital piezoelectric stimulation delivers high power outputs, improves high frequency gain for optimal speech perception, and maintains safety while providing excellent patient satisfaction.