Pediatric Ear Infection Clinical Study at Advanced ENT & Allergy

Advanced ENT & Allergy is participating in a clinical research study evaluating a new investigational device designed to help doctors learn more about middle ear infections in children.

The study is being conducted by OtoNexus Medical Technologies, Inc., with Matthew Yantis, M.D. serving as the Primary Investigator. The study is evaluating the OtoNexus Advanced Otoscope, also referred to as Novoscope, as part of a design and human factors evaluation for patients who are scheduled to undergo tympanostomy.

What Is a Middle Ear Infection?

Middle ear infections, also called otitis media, are common in children. They occur when fluid and inflammation develop behind the eardrum and can sometimes cause ear pain, pressure, hearing changes, or other symptoms.

Doctors typically evaluate a child's ears by looking at the eardrum and considering the child's symptoms and medical history. Researchers are studying new technologies that may provide additional information about the middle ear and help improve how ear infections are evaluated in the future.

About the OtoNexus Clinical Study

The OtoNexus study is evaluating an investigational otoscope designed to collect information from inside the ear using different types of technology.

The device uses photos, video, and ultrasound signals to evaluate the ear. Researchers are studying how the device works and how it can be used during an ear examination.

The goal of this research is to learn more about whether this technology may help doctors better understand middle ear infections in the future, including information that could potentially help distinguish between different types of infections.

Because the device is investigational, information collected by the device will not be used to make medical treatment decisions during the study.

What Happens During the Study?

Participation involves a brief examination of the child's ear using the investigational device.

During the study:

• A doctor will take a few measurements inside your child's ear.
• The device uses photos, video, and ultrasound signals to evaluate the ear.
• The examination takes only a few minutes.
• Results from the device will not be used for medical treatment during the study.
• A parent or legal guardian must provide informed consent for a child to participate.
• Families who participate will receive compensation.

Your child's healthcare provider can provide additional information about what participation involves and answer questions about the study.

Who May Participate?

This study is intended for children who are scheduled to undergo tympanostomy, a procedure in which small ear tubes are placed through the eardrum.

Whether your child qualifies depends on the specific requirements of the study. The study team will determine eligibility and provide additional information before participation.

Participation is voluntary. Parents or guardians can ask questions about the study before deciding whether their child should participate.

Learn More About the OtoNexus Study

The OtoNexus study is researching a new approach to evaluating the middle ear in children. By participating in clinical research, families can help researchers learn more about new technologies that may be used in ear care in the future.

OtoNexus Study Information for Parents

Download the study information sheet to learn more about the investigational device, what happens during the study, and how children may participate.

Download the OtoNexus Study Information Sheet

Interested in Learning More?

If your child is scheduled to undergo tympanostomy and you are interested in learning more about this clinical study, ask your healthcare provider whether your child may be eligible.

Primary Investigator:
Matthew Yantis, M.D.

Study Sponsor:
OtoNexus Medical Technologies, Inc.

Study:
OtoNexus Advanced Otoscope (Novoscope) Design and Human Factors Evaluation Protocol

If you are interested in learning more, contact the study team to discuss the study and whether your child may qualify. Participation is voluntary, and eligibility will be determined by the study team.