Author Contributions: Dr Rauch had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Rauch, Halpin, Carey, Gantz, Goebel, Hammerschlag, Telian, Reda.
Acquisition of data: Rauch, Halpin, Antonelli, Babu, Carey, Gantz, Goebel, Hammerschlag, Harris, Isaacson, Lee, Linstrom, Parnes, Slattery, Telian, Vrabec.
Analysis and interpretation of data: Rauch, Halpin, Carey, Goebel, Harris, Lee, Shi, Reda.
Drafting of the manuscript: Rauch, Halpin, Reda.
Critical revision of the manuscript for important intellectual content: Rauch, Halpin, Babu, Carey, Gantz, Goebel, Hammerschlag, Harris, Isaacson, Lee, Linstrom, Parnes, Shi, Slattery, Telian, Vrabec, Reda.
Statistical analysis: Shi, Reda.
Obtained funding: Rauch, Halpin, Carey, Gantz, Goebel, Hammerschlag, Harris, Telian, Reda.
Administrative, technical, or material support: Rauch, Halpin, Shi, Reda.
Study supervision: Rauch, Halpin, Reda.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Harris reported that he has a financial interest in Otonomy Inc. Drs Rauch, Carey, Gantz, and Harris reported that they have served as paid consultants of Otonomy, and Drs Rauch, Gantz, and Linstrom reported that they have been investigators in a clinical trial supported by Otonomy Inc; otherwise, no other conflicts were reported.
Funding/Support: This study was funded by grant U01-DC006296 from the National Institute on Deafness and Communication Disorders.
Role of the Sponsor: The sponsor had no role in the design and conduct of the study, in the collection, analysis, and interpretation of the data, or in the preparation, review, or approval of the manuscript.
Additional Contributions: In memory of our devoted and esteemed collaborator, Carol Y. Ota, and our early supporter and benefactor, Alex d’Arbeloff. We also wish to extend our praise and gratitude to our team of dedicated Clinical Research Coordinators, without whom this project would never have been accomplished.