Nov. 30 (Bloomberg) -- Medical devices designed to help paralyzed patients move won U.S. regulators’ approval to use a block of radio spectrum for transmitting wireless signals to incapacitated limbs.
The Federal Communications Commission adopted rules that give access needed by so-called advanced microstimulator devices that use implanted electrodes to stimulate muscles with the help of a wireless controller worn outside the body.
The devices may help stroke patients and U.S. service members suffering from spinal-cord and traumatic brain injuries, FCC staff said in the agency’s proposed rule. About 1.7 million people sustain a traumatic brain injury annually and about 200,000 are living with spinal cord injuries in the U.S., according to the Centers for Disease Control and Prevention based in Atlanta.
The frequency approved “is the most efficient for penetrating tissue with radio waves and without which the new generation of our implantable neurostimulator technology would be impossible to advance,” said David Hankin, chief executive officer of the Alfred Mann Foundation in Santa Clarita, California, which funds medical device development and asked the FCC to extend the spectrum to the products.
The airwaves at stake are in the 413-457 megahertz range and part of a block of spectrum used primarily by the federal government. Amateur radio operators have permission to use the spectrum on a secondary basis and have filed objections to the agency over the proposed use by medical devices.
Amateur Radio Opposition
The choice of frequency bands for the devices is “unfortunate and unnecessary,” the American Radio Relay League, the national association for amateur radio in Newington, Connecticut, wrote in comments to the FCC. The group said it was concerned that interference from the devices may hinder amateur radio operators and suggested the agency allocate a different block of spectrum.
The Alfred Mann Foundation plans trials this year on people with head and neck cancer who have difficulty swallowing and traumatic brain injury patients with upper-limb paralysis, according to the group’s website. The foundation didn’t return a call for comment on the trials. Alfred Mann is founder, chairman and chief executive officer of MannKind Corp., a biotechnology company based in Valencia, California.
Some electrical stimulation systems with electrodes on the skin that activate major leg and pelvis muscles have been approved, according the Cleveland FES Center in Ohio, which studies functional electrical stimulation to help those with muscular skeletal or neurological impairments.
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