Pivotal Clinic Study of the H-TTS

The H-TTS is indicated for patients undergoing a tympanostomy tube procedure. The H-TTS is
intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a
tympanostomy procedure.

The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to
deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a
tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in
the US, making it one of the most common surgical procedures performed in children. Most ear
tubes are inserted by otolaryngologists using either local anesthesia (usually adults) or
general anesthesia (usually children).

Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the
patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple
surgical instruments necessary for current surgical procedure into a single, one-pass device.
The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a
tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a
tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is
a standard, commercially available tympanostomy tube. The H-TTS has been cleared by the FDA
for use in a hospital or ASC setting under both general anesthesia and moderate (conscious)
sedation.

The study will be a multi-site, prospective, treatment-only study of the H-TTS. Enrollment in
the study at each site will begin after receipt of Institutional Review Board (IRB) approval.
50 to 200 patients will be included at 3-10 clinical sites.

Inclusion Criteria:

- Scheduled to undergo tympanostomy tube insertion in the clinic.

- Ages ≥6 months through ≤24 months or ≥5 years through ≤12 years.

- Signed parental consent, and child assent documents as applicable.

- Parent is fluent in English.

Exclusion Criteria:

- Any condition that, in the opinion of the investigator, may place the subject at
greater risk (e.g., child with developmental delay).

- Anatomy precludes sufficient visualization and access to the tympanic membrane.