Alpha-Stim Gains Support of Medical Professionals and Patients in Opposing New FDA Rule

The FDA’s backwards ruling on already-established cranial electrotherapy stimulation use is upsetting to businesses and consumers alike.

Alpha-Stim, cranial electrotherapy stimulation (CES) devices providing treatment for anxiety, depression, insomnia, and pain, announces its user-supported campaign to change an FDA rule regarding Pre-Market Approval (PMA), the medical device equivalent of a new drug application. FDA is proposing a rule that would now require PMA for CES, while for the past 30 years CES devices have been legally cleared to market in the USA by FDA.

Approved for over the counter sales in Europe, China, and Canada, the Alpha-Stim devices have gone through an extensive review process for the FDA six times since 1981 and have been cleared to market. Alpha-Stim is highly respected in the medical industry (doctors, psychologists, addiction professionals, etc.) and military communities, resulting, to date, in over 100 written objections to this proposed rule on behalf of Alpha-Stim, indicating its safety, lack of side effects, and above all, its effectiveness.

Texas Congressman Joe Barton has recently submitted the following statement to the Congressional Subcommittee on Oversight and Investigations: “The Medical Device Review Process at the Food and Drug Administration (FDA) has become overly burdensome, unpredictable and inconsistent under its current leadership…Small companies and entrepreneurs want to create businesses and design products that will help save lives and be profitable.”

In its comments to the proposed rule submitted to FDA docket No. FDA-2011-N-0504-0078 on October 12, 2011, Alpha-Stim has focused on three main areas of concern in the proposed rule:

FDA’s review of the science

FDA’s review of safety data

FDA’s evaluation of the economic impact of this ruling

EPI inc., Alpha-Stim’s parent company, is asking for the “valid scientific evidence” provided to FDA for CES be reviewed thoroughly and fairly. EPI asks that FDA review all of the safety data provided and revise the findings within the proposed rule. EPI has provided the FDA with valid scientific evidence showing:

99.9% of actual Alpha-Stim users considered the device effective.

Only 11 out of over 50,000 Alpha-Stim users (less than 0.02%) reported adverse effects from using Alpha-Stim.

49 completed studies and 12 on-going studies conducted on Alpha-Stim support the safety and effectiveness of the device.

The economic impact of the ruling is to impose a process that the FDA estimates will cost the company $1 million, for a product they approved over 30 years ago. Alpha-Stim and its supporters find the ruling overly aggressive and in complete opposition to all the positive information found in studies that Alpha-Stim diligently provided.

Through the use of its proprietary waveform, Alpha-Stim technology applies a mild electrical current via electrodes that clip onto the earlobes. The waveform works effectively in a safe and controlled manner to gently coax the brain’s electrical signals to normalize. The result is safe and effective treatment of anxiety, depression, insomnia, and pain. Alpha-Stim works with the body instead of against it, and is non-invasive and gentle as compared to the strong electrical signals from other devices used in both physical medicine and psychiatry. The devices also operate without the side effects that are common to prescription medications.

To view the FDA docket including proposed rule and letters of support for Alpha-Stim, please visit and search using the proposed rule’s docket number: FDA-2011-N-0504.

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