Device Overview
| Attribute | Detail |
|---|---|
| Device Name | HeartBeats™ Fetal Doppler |
| Manufacturer | SonoHealth |
| FDA Status | FDA-cleared (510(k)) |
| Device Class | Class II medical device |
| Probe Frequency | 2.5 MHz |
| Intended Use | Home fetal heart rate monitoring for reassurance and bonding |
| Not Intended For | Clinical diagnosis, fetal distress monitoring, or replacement of prenatal care |
FDA Clearance Status
The HeartBeats™ has received FDA 510(k) clearance, meaning it has been reviewed by the FDA and found to be substantially equivalent in safety and effectiveness to a legally marketed predicate device. It is labeled in accordance with FDA medical device regulations. This clearance differentiates it from many generic marketplace dopplers that are sold without FDA review or authorization.Appropriate Use in the Patient Population
The HeartBeats™ is appropriate for use by:- Expectant parents (uncomplicated pregnancies) who wish to hear the heartbeat for bonding and reassurance between prenatal appointments
- Midwives and doulas as a portable adjunct tool for home visits
- Childbirth educators as a demonstration device
- Monitoring high-risk pregnancies as a primary monitoring tool
- Self-assessment of fetal distress
- Replacement of Non-Stress Tests (NST) or clinical Doppler monitoring
- Use by patients who have been advised against home monitoring
Key Clinical Considerations
Reassurance vs. false reassurance: Providers should counsel patients that a detectable heartbeat does not confirm fetal well-being and should not be used to postpone seeking care when concerns arise. Reduced fetal movement: Patients experiencing reduced fetal movement should contact their provider immediately — not reach for their home doppler. A detectable heartbeat does not rule out fetal compromise. Early pregnancy use: Detection before 12 weeks is unreliable with a home doppler. Providers should set appropriate expectations to avoid patient anxiety when the heartbeat cannot be detected in the first trimester. Placental and maternal sounds: Patients should be educated on the difference between fetal heart tones (120–180 BPM), placental sounds, and maternal pulse to reduce misidentification.Guidance to Share with Patients
We recommend the following framing when discussing home fetal dopplers with patients:“A home fetal doppler can be a nice bonding tool, but it’s for reassurance and listening — not for monitoring. If you ever have concerns about your baby’s movement or your pregnancy, call us first — don’t rely on the doppler to tell you everything is fine.”Patients using the HeartBeats™ should:
- Use it occasionally for bonding — not daily as a substitute for kick counts or clinical monitoring
- Know how to distinguish fetal heart rate from maternal pulse
- Understand that an inability to find the heartbeat is common and not always a sign of a problem
- Always contact their provider with concerns — not rely on the doppler for reassurance in potentially urgent situations
Probe Frequency and Clinical Context
The 2.5 MHz probe in the HeartBeats™ is the standard frequency for handheld consumer and clinical Doppler devices used from the second trimester. It provides adequate depth penetration for tranabdominal fetal heart detection in typical patients from approximately 12 weeks. Clinical Doppler devices used by providers may use similar frequencies but differ in their display capabilities, transducer quality, and build specifications.Contact & Support
For questions about the HeartBeats™ or for bulk/professional purchasing inquiries, contact SonoHealth at sonohealth.com/contact.Shop HeartBeats™ Fetal Doppler
FDA-Cleared · 2.5 MHz · 2-Year Warranty · $79