Examining the Healy "Bioresonance" Device from a Critical Perspective
Background History
Bioresonance therapy is a treatment that claims to cure diseases by correcting abnormal frequencies based on the belief that every cell in the body has its own electromagnetic frequency. The origin of this idea can be traced back to Albert Abrams, M.D., who was criticized by the American Medical Association as the "dean of gadget quacks" for exploiting the concept that diseases could be cured by radio frequency energy in the 1920s and 1930s. Today, Rife derivatives are still being marketed.
Franz Morell, a German physician, is attributed to the development of bioresonance therapy. Morell investigated the use of electroacupuncture devices and helped Hans Brügemann create the BICOM, which Brügemann coined the term "bioresonance therapy" to describe in 1987. However, according to Professor Edzard Ernst, Brügemann and subsequent bioresonance promoters have used "pseudo-scientific language" to present nonsense as science. Recent research has shown that two current BICOM equivalents have failed to diagnose serious diseases in two seriously ill patients, produced a clean bill of health for a corpse, diagnosed a host of nonexistent health risks in nine healthy volunteers, generated no real differences between a wet towel and the volunteers, and had wildly variable results with repeated tests of the wet towel and liver pate.
The Healy is a portable device claimed to be a descendant of the BICOM and developed by Marcus Schmieke and Nuno Nina, according to the Healy GmbH website. Schmieke, the inventor and developer of the Healy and TimeWaver products, had envisioned a compact and practical device that everyone could use daily to benefit from the possibilities of TimeWaver technology. On the other hand, Nuno Nina, a Portuguese researcher and holistic healer, has extensive experience with frequency applications and cell biology, and has compiled a collection of 144,000 "Gold Frequencies" based on his research with thousands of clients. When Nina first encountered TimeWaver technology, he saw the potential to combine it with frequency therapy to create something greater than the sum of its parts.According to the timeline on the TimeWaver website, TimeWaver development began in 2007, and the first Healy device was developed in 2015.
Fanciful Claims
According to a Facebook page associated with Healy in 2020, the human body is composed of 100 trillion cells, each requiring healthy cell voltage to survive. Quantum physics suggests that energy and matter are the same thing, which implies that we are all energy. Motion-creating resonance is what drives everything within us, according to quantum physics. Understanding how subtle energy directs and maintains human health and wellness is crucial, given this fact.
Consider a wearable portable technology that has been developed to enhance overall health, both inside and out. This technology assists with energetic imbalances by directing cell communication and increasing cellular energy (ATP) by 500%, which helps to restore balance to the body (homeostasis). Our cells communicate with one another through resonant frequency, which is similar to tuning your radio or television to a specific channel. The difference between tuning to 102.3 or 102.4 is the difference between a clear signal and static (a signal disruptor). The power is in the resonance.
Just like anything else, our cells serve as transmitters and receivers. The way in which our cells transmit and receive communication is crucial and can have a direct impact on our health through their signal calling. Just as a good signal can be disrupted by a poor and unhealthy lifestyle or environmental factors, a bad signal can be intentionally disrupted (symptomatic poor health). Focusing on healthy frequency communication between cell function can have a significant impact on our health, vitality, and brain function in ways that we may not even be able to imagine.
Another affiliated site has added:
According to the information available, the Healy uses a quantum sensor to measure an individual's frequency. It then provides customized and specific frequencies to realign the cellular, emotional, and energy centers and bring them back into bioenergetic balance. Essentially, the Healy communicates with cellular energy to understand the healing needs of the cells and delivers the exact frequencies required for healing.
A Healy video commercial has said:
With Healy, you can stay connected to the Cloud through your smartphone and access a wide range of frequencies recommended by therapists and clinicians. This technology is available to everyone and marks the beginning of a new era where cellular bioenergetic regeneration will be just as crucial to our health as maintaining a healthy diet and regular exercise.
In 2020, a “Healy Programms” brochure promised more than a hundred benefits, including:
Bioenergetic stimulation of the body's energy supply, cell metabolism, and mental clarity.
Bioenergetic balancing to help relieve allergic reactions and reduce tensions.
Bioenergetic regulation of thyroid function and hormonal balance.
Bioenergetic promotion of liver metabolism, toxin transport, and the lymphatic system.
Energetically balancing the immune system in cases of infections.
Bioenergetic optimization of lung function.
Bioenergetic reduction of interference fields in scars.
Bioenergetic calming of the mucous membranes.
Bioenergetic balancing of visual ability, the hormonal system, the nervous system, the reproductive organs, the body's excretory processes, the follicles, and the nail bed.
Supports inner balance to aid recovery from nicotine addiction.
Regulation of bladder energy control.
Stimulation of the energy field of the spleen and pancreas.
Healy offers a Digital Nutrition App that, when used with a basic Healy device, supposedly harmonizes your bioenergetic field.
The app claims to select individual Healy DNA frequency programs for you and create lists of foods that naturally contain the required substances. The DNA programs contain the resonance frequencies for the individual substances and supposedly support better absorption of these substances from your food. However, many of Healy’s marketing materials come with a disclaimer stating that “Healy and its applications are not acknowledged by orthodox medicine due to a lack of scientific proof in accordance with scientific standards.”
It should be noted that claims made by proponents of Healy's technology are not only unproven, but there is no logical reason to believe that the frequencies they describe are actual physical forces. Nonetheless, they continue to suggest that these frequencies offer great health benefits.
Regulatory Status
According to FDA regulations, devices that have obtained 510(k) clearance can be legally sold in the US for their intended purposes. To obtain this clearance, manufacturers must demonstrate that the device is substantially similar to a previously cleared or approved device, but are not required to prove its efficacy.
. The Healy, a Class 2 medical device, received 510(k) clearance from the FDA in 2019 for temporary relief of pain associated with muscle strain and for the management of chronic pain and arthritis. The device was described in the application as being similar to Omron's Avail, a TENS device used for pain relief. TENS devices are believed to relieve pain by releasing endorphins and blocking pain transmission through nerves.
The Healy is only legally cleared for use as a TENS device, and any claims made by the manufacturer regarding the device's ability to prevent, cure, mitigate, or treat diseases would be illegal. The marketing materials related to "bioresonance" are not cleared by the FDA.
Healy may argue that its claims regarding frequencies and "energetic balance" are not medical claims, and that its use is intended for wellness and stress relief rather than disease treatment. However, the context in which claims are made determines their intended use. The use of artful language does not change the fact that claims related to organs or diseases are considered medical claims and require FDA approval. Additionally, the Federal Trade Commission Act requires advertising to be truthful and not misleading, and health-related claims must be supported by scientific evidence. Healy admits that it lacks such evidence.
Some websites have claimed that the Healy is FDA-approved, but this is incorrect. Approval requires clinical trials to demonstrate safety and effectiveness, whereas Healy has only obtained 510(k) clearance. The "Certificate of Approval" issued by Harrington Consulting accurately describes the clearance, but the use of the word "approval" may be misleading. In Australia, the Healy is registered as an "analgesic TENS system," despite not actually being one.
In March 2021, the FDA directed 25 companies to cease issuing certificates claiming that they have registered with the FDA. The FDA is concerned that these certificates could falsely imply that the devices have undergone evaluation, clearance, or approval for their intended purposes. It is important to note that the FDA does not provide any device registration certificates, and registration with the FDA does not indicate approval or clearance of the establishment or its devices. While the FDA's action specifically pertained to registration certificates, I believe that the same principles would apply to "clearance certificates."
BICOM’s Regulatory Status
The BICOM device, from which Healy claims to have originated, is not listed in the FDA's 510(k) database. In 2015, the British Advertising Standards Association (ASA) ordered Bicom UK, based in Leeds, West Yorkshire, to discontinue its claims that its "bio-resonance" machines can effectively treat various conditions such as allergies, food intolerances, infections, viruses, cancer, and more. Similarly, in 2019, the ASA ordered Wayne Hardwick (doing business as Body Resonance) to stop making claims or insinuations that Bioresonance could treat medical conditions unless there was sufficient evidence to support such claims. The ASA has also stated in an advisory that it has yet to see any evidence demonstrating that the devices used in bio-resonance therapy can diagnose existing or future medical conditions or prevent or treat diseases or illnesses.
The BICOM device was registered as a biofeedback device in Australia, but there were repeated complaints to the Therapeutic Goods Administration (TGA) from Friends of Science in Medicine between 2014 and 2018 that the BICOM and CyberScan were marketed improperly and were not actually biofeedback devices. Biofeedback devices respond to physiological phenomena such as heart rate, blood pressure, or muscle tone to improve health outcomes. In 2019, the TGA announced it would take action against improper claims made for bioresonance devices and reviewed evidence provided by marketers to support the intended indications for their devices. As a result, BICOM marketers canceled its registration, and the TGA canceled the registration of two other devices (Cyberscan and e-Lybra). In 2020, a skeptic complained to the TGA about Healy devices. In March 2022, the TGA announced that it had issued two infringement notices totaling AU$26,640 to Healy World Australia Pty. Ltd. for advertising an "analgesic TENS system" in alleged breach of the Therapeutic Goods Act 1989. The announcement stated that the company had advertised the device for a purpose other than its registered purpose and its advertising contained prohibited representations that referred to depression, anxiety, and associated sleep disturbances.
Conclusion
Healy devices have been promoted as a remedy for a broad range of health concerns, but their effectiveness is based on concepts that may appear scientific, but lack empirical validation. While the FDA has granted clearance for Healy devices to be sold in the United States for temporary pain relief, claims made for their use extend well beyond the scope of this clearance. The marketers of Healy have even acknowledged that there is no scientific evidence to substantiate their advertised benefits.