Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.

This clinical study is designed to evaluate the performance and safety of the Keikku electronic stethoscope, an innovative medical device developed by Lapsi Health Holding BV. The Keikku device combines a micro-electromechanical system (MEMS) sensor with a Bluetooth-enabled smartphone application, allowing physicians to capture and review heart sounds in real-time or via secure cloud storage.

The Keikku electronic stethoscope differs from traditional stethoscopes in that it digitally records and transmits auscultation sounds without interpreting them. Physicians use the Keikku Mobile Application to listen, annotate, and share these sounds. This study assesses whether such a device can match the diagnostic capabilities of conventional analog stethoscopes, particularly in detecting heart murmurs.

This is a prospective, open-label, controlled clinical investigation involving 149 pediatric and adult participants (from birth to age 99) in non-urgent cardiac evaluations. Each participant undergoes two sequential heart sound assessments at four standard precordial chest locations (mitral, tricuspid, aortic, and pulmonary):

Keikku electronic stethoscope: used by a physician listening via Bluetooth headphones.

Conventional stethoscope: used by a second, blinded physician.

Each device's use is independently evaluated using predefined clinical report forms. Physicians record whether a murmur is present and rate the acoustic quality of the auscultation on a 5-point Likert scale.

To ensure objectivity, physicians do not communicate their findings, and the second physician has no access to the recordings or results obtained by the first. All recordings (both digital and analog) are stored on GDPR-compliant cloud servers. Final clinical decisions about patient care are based only on the findings of the conventional stethoscope, not the investigational device.

The study's primary endpoint is the agreement percentage between the Keikku and conventional stethoscopes in murmur detection. Secondary and exploratory endpoints include the incidence of device-related adverse events, the sensitivity and specificity of murmur detection, user-reported sound quality, and any technical issues (device deficiencies) encountered.

Participation in this study lasts only one day and involves no follow-up visits. No treatment decisions are made based on the investigational device. The research is conducted at a single site in Peru, and the data will contribute to a broader understanding of digital stethoscope performance in clinical environments.

By validating the diagnostic capabilities of the Keikku electronic stethoscope, this study aims to support the safe integration of digital auscultation technology into everyday clinical care and remote telemedicine applications.

Inclusion criteria

• Pediatric, including newborn (from birth to 1 month of age), or adult (aged 99 or below) individuals.
• Individuals who are either:

• presenting for initial, non-urgent outpatient evaluation of a cardiac murmur or for non-urgent cardiac clearance; or
• presenting for return, non-urgent outpatient evaluation of a cardiac murmur; or
• undergoing initial or recurrent, non-urgent evaluation of a cardiac murmur in inpatient setting; or
• undergoing non-urgent cardiac clearance in inpatient setting.

Exclusion criteria

pregnant female individuals