Statement of the Approved use of Hi! Baby Sounder Fetal Doppler


Clarification of the proper way to obtain the Hi!BabySounder at-home fetal doppler monitor for home use and patient use.

Unlike most other medical devices that exist in one broad category and are available by prescription only, fetal dopplers are unique as they are available in two wide categories – the complex fetal dopplers for medical professional (by prescription only) and the simpler at-home device for public use (available online for purchase with no extra steps needed). The good news is that according to the Food and Drug Administration, not all medical devices require a prescription!

It is easy to confuse a Doppler ultrasound machine (needs prescription) used at a doctor’s office with the at-home fetal doppler monitor as they are both used to check the baby’s heartbeat. However, the Doppler used by a doctor uses higher frequency sound waves and can produce sounds and even images. At-home handheld monitors such as the Hi!BabySounder transmits at a lower frequency and only provides sound. When used appropriately and according to the manufacturer’s guidelines, at-home fetal dopplers are generally safe, can reduce a false sense of security, reduce panic, and can also be a useful tool for listening to a baby’s heartbeat in the comfort of home.

Hi!BabySounder was cleared by the Food and Drug Administration prior to marketing in the United States. The Hi!BabySounder fetal doppler monitor manufactured by has duly approved and received a Class II Obstetrical and Gynecological Monitoring Device 510 (k) clearance from the FDA which means that it has been demonstrated to be safe and effective and is substantially equivalent to legally marketed device (section 513(i)(1)(A) FD&C Act) and thus, can be marketed in the United States as is.

A premarket notification 510(k) typically requires submission of detailed clinical, technical, safety, and performance information about the product from the manufacturer (in this case,, a rigorous review, and subsequent approval from the FDA once the product is shown to fully comply with all medical directives for the intended use.

Hi!BabySounder is approved as an “Obstetrical and Gynecological Monitoring Device” and a fetal ultrasound monitor and accessory. Individuals can purchase their own fetal doppler accessory to listen to their baby’s heartbeat.

For safety, the FDA requires that certain medical devices and services be obtained by prescription only. Medical-grade doppler devices used by a doctor or midwife in office settings are prescriptive medical devices, and according to the FDA, these complex dopplers are designed to be used by healthcare professionals only. The use of these in-clinic dopplers is often more complicated and require the right training for proper use.

Since not all medical devices require prescription, the FDA routinely approves some medical devices for sale directly to the consumer and these devices and products are usually available at many online retailers. Just be sure you are buying from an approved and reliable source. Also be sure you follow the FDA’s guidelines on how to use and maintain your medical device safely and effectively in your home.

In general, at-home dopplers, also known as doptones or doppler probes, transmit at a lower frequency and are simpler to use than the doppler used by a medical practitioner in a medical setting. Although the Hi!Baby Sounder fetal doppler can be purchased directly from retailers at convenience, our product is not intended to replace a regular doctor’s visit. Instead, Hi!BabySounder can be used in between doctor’s appointments as a way to connect to the unborn baby by listening to their heartbeat. Our product is also not intended as medical guidance, diagnosis, or treatment and should never replace proper medical advice and consultation. As with every other medical products, users should follow the manufacturer’s guidelines for proper use and should also consult with their healthcare provider about the role of the Hi!BabySounder doppler in their pregnancy journey to make sure the product is right for them and aligns with their pregnancy goals for the best pregnancy outcome.

We remain committed to providing FDA-cleared, safe, effective, and affordable medical products for consumers. We hope our Hi!BabySounder fetal doppler monitor, which is available online, continues to offer peace and calm to soon-to-be mothers as they navigate their way through the many uncertainties of pregnancy as the weeks pass by.

If you need any more information about Hi!BabySounder, we can be reached at

Mail: 1185 Avenue of the Americas – 3rd Floor, New York, NY 10036 USA

Toll free number: 1-833-838-V6CO (8626)


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