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Clinical & Regulatory Notice: This reference provides technical, signal-processing, and regulatory information from U.S. FDA 510(k) summaries and peer-reviewed clinical studies for health informatics and clinical research professionals. It does not provide individual medical advice or clinical diagnostic instructions.
Cardiovascular researchers, telemedicine architects, and primary care clinical informatics leads evaluating an Eko stethoscope (or Eko digital stethoscope) examine both its acoustic-electrical hardware and its FDA 510(k)-cleared machine learning software suite (Eko Murmur Analysis Software / SENSORA). By combining digital acoustic amplification and active noise cancellation with synchronous phonocardiogram (PCG) and electrocardiogram (ECG) capture, Eko devices transform traditional bedside auscultation into quantifiable digital biomarkers for structural heart disease screening, virtual care tele-auscultation, and decentralized clinical trials.
What Is an Eko Stethoscope?
An Eko stethoscope is an FDA Class II electronic stethoscope and cardiopulmonary sensor platform developed by Eko Health. Regulated under 21 CFR § 870.1875(b) (Electronic Stethoscope, product code `DQD`) and, for ECG-equipped models, 21 CFR § 870.2340 (Electrocardiograph, product code `DPS`), the hardware captures, amplifies (up to 40×), filters, and digitizes heart and lung sounds alongside surface ECG leads, streaming synchronized waveform data via Bluetooth Low Energy (BLE) to the Eko mobile app, cloud dashboard, and enterprise EHRs.
Hardware Models Compared: Eko CORE Attachment vs. Eko DUO vs. Eko CORE 500
Unlike conventional acoustic stethoscope types, the Eko hardware portfolio spans modular inline digital attachments and integrated multi-lead ECG digital chestpieces:
| Hardware Model | Acoustic Sensor & Amplification | Integrated ECG Leads | Primary Clinical & Research Use Case |
|---|---|---|---|
| Eko CORE (Digital Attachment & Stethoscope) | Inline piezoceramic/MEMS acoustic transducer with up to 40× amplification, active noise cancellation (ANC), and analog acoustic bypass mode. | None (PCG audio and waveform only). | Retrofitting existing analog stethoscopes (such as 3M Littmann Cardiology models) for digital amplification, PCG recording, and live tele-auscultation streaming. |
| Eko DUO | Digital acoustic diaphragm with 7 selectable amplification levels and 4 audio filter modes (Diaphragm, Bell, Midrange, Extended). | 1-Lead ECG via two stainless-steel dry electrodes integrated on the chestpiece face. | Simultaneous single-lead ECG and PCG time-series capture for heart failure clinics, arrhythmia screening, and remote patient monitoring (RPM). |
| Eko CORE 500™ | TrueSound™ digital audio with in-ear speakers in the headset, active noise cancellation, and full-color on-chestpiece display showing heart rate and ECG trace. | 3-Lead ECG via three integrated chestpiece electrodes. | Point-of-care structural murmur, atrial fibrillation, and Low Ejection Fraction (Low EF) AI screening with multi-angle cardiac electrical vectors. |
How Is the Eko Stethoscope Used in Clinical Research and Healthcare?
In clinical practice and cardiovascular trials, the Eko platform connects bedside physical examination with automated signal processing and remote specialist review across three core workflows:
1. Synchronous Phonocardiogram (PCG) and ECG Signal Acquisition
Unassisted human auscultation struggles to time low-frequency diastolic murmurs or subtle S3/S4 gallop rhythms at elevated heart rates. When an Eko DUO or CORE 500 records a 15-second cardiac examination across the four standard auscultation sites (aortic, pulmonic, tricuspid, and mitral), it captures two synchronized physiological channels:
- Phonocardiogram (PCG) Channel: Digitizes acoustic vibrations across cardiac (typically 20–200 Hz, bell/diaphragm bandpass) and pulmonary (100–2,000 Hz) frequency bands, rendering visual amplitude-over-time waveforms and spectrograms.
- Electrocardiogram (ECG) Channel: Captures the surface electrical depolarization/repolarization waveform (P wave, QRS complex, T wave), providing an exact fiducial timing reference to segment each cardiac cycle into systole (between S1, aligned just after the QRS onset, and S2, aligned near the end of the T wave) and diastole (between S2 and the subsequent S1).
2. FDA 510(k)-Cleared AI Algorithms (EMAS, AFib, and Low Ejection Fraction)
Paired with the Eko enterprise software suite (SENSORA™), Eko has obtained multiple U.S. FDA 510(k) clearances for deep neural network algorithms that analyze PCG and ECG signals at the point of care:
| FDA 510(k) Algorithm | 510(k) Number & Modality Inputs | Clinical Screening Target | Reported Validation Performance (vs. Echocardiogram / 12-Lead ECG Ground Truth) |
|---|---|---|---|
| Eko Analysis Software (EAS) | K192004 (PCG + 1-Lead/3-Lead ECG) |
Automated detection of presence of heart murmurs, atrial fibrillation (AFib), tachycardia, and bradycardia. | AFib Detection: ~98.9% sensitivity and ~96.9% specificity on simultaneous 1-lead ECG; overall murmur detection sensitivity ~87.6% and specificity ~87.8%. |
| Eko Murmur Analysis Software (EMAS) | K220626 (PCG across standard auscultation sites) |
Distinguishes structural (pathologic) heart murmurs (valvular heart disease) from innocent/functional murmurs and normal heart sounds in adults and pediatrics. | Structural Murmur Identification: ~85.6%–90.2% sensitivity and ~84.4%–91.3% specificity against clinical echocardiography in multi-center validation studies. |
| Eko Low EF AI Algorithm | K233409 (Cleared April 2024; Breakthrough Device Designation) (Synchronous PCG + ECG) |
Point-of-care screening aid to detect reduced left ventricular ejection fraction (LVEF ≤ 40%, HFrEF) during a 15-second routine stethoscope exam in adults at risk for heart failure. | Validated in clinical studies (AUROC ~0.85, sensitivity ~74.7%–81%, specificity ~77.5%–86% depending on operating threshold) to flag undiagnosed systolic dysfunction for confirmatory echocardiography. |
Regulatory Scope: All FDA-cleared Eko AI algorithms are indicated as clinical decision support screening aids to supplement—never replace—physician interpretation and diagnostic echocardiography or 12-lead electrocardiography.
3. Synchronous Telemedicine Auscultation and Decentralized Clinical Trials (DCTs)
In virtual care and rural telehealth spokes, a remote cardiologist or pulmonologist cannot examine a patient using a standard webcam. As a telemedicine stethoscope, the Eko platform supports two tele-auscultation architectures:
- Synchronous Live Streaming (Telehealth Mode): A bedside nurse, medical assistant, or patient at a spoke clinic places the Eko stethoscope on the chest while connected to the Eko App via Bluetooth. Over an encrypted WebRTC/TLS stream, the remote physician hears lossless filtered auscultation audio in real time through headphones and views live scrolling PCG and ECG waveforms on a web dashboard or integrated virtual care console.
- Asynchronous Store-and-Forward & Digital Health Technologies (DHTs) in Clinical Trials: In heart failure, valvular disease, and cardiopulmonary drug/device trials, site coordinators or home-visiting nurses record standardized 15-second four-posture auscultation protocols. Time-stamped `.wav`/JSON PCG-ECG files and automated AI screening outputs are uploaded to the cloud study repository or attached to the EHR via HL7® FHIR® `Observation`, `Media`, and `DiagnosticReport` resources.
Frequently Asked Questions
What is an Eko stethoscope?
An Eko stethoscope is an FDA Class II digital stethoscope and cardiopulmonary sensing platform (including the Eko CORE attachment, Eko DUO, and Eko CORE 500) regulated under 21 CFR § 870.1875(b). It combines up to 40x acoustic amplification and active noise cancellation with Bluetooth waveform streaming and, on DUO and CORE 500 models, integrated 1-lead or 3-lead ECG electrodes for synchronous phonocardiogram (PCG) and electrocardiogram (ECG) capture.
How is the Eko stethoscope used in clinical research and healthcare?
Clinicians and researchers use Eko stethoscopes for amplified bedside auscultation, FDA 510(k)-cleared AI screening of structural heart murmurs (K220626), atrial fibrillation (K192004), and reduced left ventricular ejection fraction ≤ 40% (K233409), real-time synchronous tele-auscultation in telemedicine clinics, and standardized digital PCG/ECG biomarker collection in cardiovascular clinical trials.
How does a digital stethoscope work for telemedicine?
During a telemedicine encounter, the bedside nurse or patient pairs the Eko digital stethoscope via Bluetooth to a mobile device or telehealth cart. The device digitizes and filters chest sounds and ECG traces, streaming lossless audio and live scrolling PCG/ECG waveforms over an encrypted cloud connection so a remote physician can listen through headphones and inspect waveforms in real time or via store-and-forward EHR links.
