Shelagh A. Cofer, M.D.

Closed for Enrollment

• Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer Rochester, Minn.

  The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

• Otonexus Ultrasound Otoscope Design and Human Factors Evaluation Protocol Rochester, Minn.

  The purpose of this study is to evaluate usability of the OtoNexus device when used in pediatric and adult patients in a clinical setting to detect middle ear effusion, and to determine if it is viral, bacterial, or mucoid.

   

   

• Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic: A Non-Significant Risk Study (H-TTS) Rochester, Minn.

  The objective of this study is to evaluate the safety and performance of the H-TTS for the placement of ear tubes in patients undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.