Sonitus Continues Climb Toward Reimbursement With Series D

One venture capitalist likens the pursuit of Food and Drug Administration approval for a medical device to climbing a mountain. A company grunts, grabs, pulls and scrambles to the top, expecting to enjoy a clear vista to the horizon. But once they stand astride the summit they can only eye an even higher peak – obtaining the necessary codes for reimbursement by payors. Hearing assistance device company Sonitus Medical Inc. finds itself standing atop the first peak. Early last year, the company obtained 510(k) notification for its non-surgical hearing assistance device to be used in patients with single-sided deafness. The culmination of five years of work, the FDA approval positioned Sonitus to compete in – and company officials hope ultimately to expand – the $100 million market for devices for conductive hearing loss. But to do that effectively, the company still needs to convince the Centers for Medicaid and Medicare Services and private payors.

Obtaining reimbursement shouldn’t be difficult. Sonitus moves into the established market for conductive hearing devices – which transmit sound through vibrations of the bone rather than merely amplifying noise. Its...