Does Valkee’s earlight work, because it is approved as a medical device?

When the refurbished Valkee-2 device was launched in September 2013, Valkee’s marketing tried to defend its claims with a crude statement about Their advertorials on partnering websites came with a text which points have been repeated ever since, if somebody questioned the efficacy of the earlight:

  • Valkee has been tested clinically for both treatment efficacy and user safety according to the requirements of the EU Medical Device Directive (93/42/EEC) and is consequently an approved European medical device in Class 2a for treating Seasonal Affective Disorder (SAD, Winter blues) and its many symptoms, and is CE-marked for that. Many other additional health benefits of bright light are being studied currently, by Valkee and by others, including health technology majors. All clinical studies of Valkee since mid-2012 have been double-blind, placebo controlled, even if not all have been published to protect new IPR, nor is there any requirement to publish all.

The device is approved and must therefore be effective for Seasonal Affective Disorder. The rest is elusive, and there may be some results some day. We may not publish these.

The company claims further to study the effects of bright light as a part of the health tech industry. Valkee knows very well, that earlight, or their euphemism “transcranial bright light”, has nothing to do with true bright light. Their last line of defense is in any case, that the scam device was officially approved.

Valkee’s website had a link to a “CE Class II(a) medical device certificate” for years:

The linked file can be downloaded here. It says very clearly, that the product quality was tested. No word about any efficacy check. VTT Expert Services Ltd. (the only notified body in Finland), which ok-ed the device for approval, never had the competence to check for efficacy.

The document disappeared from Valkee’s website the very same week.

Conclusion: No independent 3rd party confirmed the efficacy of the earlight device.

2 thoughts on “Does Valkee’s earlight work, because it is approved as a medical device?

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