To evaluate the characteristics and spontaneous recovery of tinnitus related to idiopathic sudden sensorineural hearing loss (ISSNHL).
Retrospective analysis from two randomized placebo-controlled clinical trials for treatment of ISSNHL within 48 hours from onset (Study A), or of tinnitus related to ISSNHL within 3 months from onset (Study B).
Forty-eight European sites (academic tertiary referral centers, private ENT practices).
One hundred thirteen adult patients of which 65 with hearing loss ≥30 dB (Study A) and 48 with persistent acute tinnitus (Study B) at baseline.
Intratympanic (i.t.) injection of placebo gel in single dose or in triple dose during 3 consecutive days.
Frequency of tinnitus, subjective tinnitus loudness, rates of complete tinnitus remission, and complete hearing recovery during 3 months follow-up.
In acute ISSNHL, tinnitus loudness decreased rapidly in cases of mild-moderate hearing loss, and tinnitus had completely resolved in two-thirds of patients after 3 months. Hearing recovery preceded tinnitus resolution. When associated with severe-profound hearing loss, tinnitus improved significantly less. Complete hearing recovery and full tinnitus remission were both about three times more frequent in mild-moderate hearing loss patients than in severe-profound cases. Improvement in tinnitus loudness over time can be approximated by a negative exponential function.
Prognosis for ISSNHL-related tinnitus is relatively poor in case of severe-profound hearing loss and the longer it has persisted. Alleviation or management of tinnitus should be a key therapeutic objective especially in pronounced ISSNHL cases.
*Department of ENT, Head and Neck Surgery, German Armed Forces Hospital Ulm, Ulm, Germany
†Department of Audiology, Cambridge University Hospitals, Cambridge, United Kingdom
‡Department of ENT, Head and Neck Surgery, Jessa Hospital, Hasselt, Belgium
§Department of ENT, Head and Neck Surgery, Martha Maria Hospital, Munich, Germany
||Auris Medical AG, Basel, Switzerland
Address correspondence and reprint requests to Thomas Meyer, Ph.D., Auris Medical AG, Falknerstrasse 4, 4001 Basel, Switzerland; E-mail: email@example.com
The study was supported in full by Auris Medical AG. M.S. and D.B. received honoraria from the Sponsor for work as medical experts related to discussions with a regulatory body; D.B. and G.M. received honoraria from the Sponsor as speakers in a scientific symposium; M.S. received honoraria from the Sponsor for serving as safety officer for Study B. T.M. is the Chairman, Chief Executive Officer and a major shareholder of Auris Medical Holding AG.
The other authors disclose no conflicts of interest.
This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives License 4.0, where it is permissible to download, share and reproduce the work in any medium, provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/4.0