Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: MONDAY, December 6, 1993 TAG: 9312060072
SECTION: VIRGINIA PAGE: C-1 EDITION: METRO
SOURCE: CAROLYN CLICK STAFF WRITER
DATELINE: LENGTH: Long
Whichard, national president of the Academy of Dispensing Audiologists, believes every office that sells hearing aids should have an audiologist on staff to conduct extensive testing of the hearing-impaired person.
"We are literally at a crossroads, a big one," she said. "I want to make sure when we come out on the other side, change is real."
But Roanoke-area licensed hearing-aid specialists say such a change would be a blow to consumers, who might find their choices of hearing-aid services severely curtailed.
"We really don't look for it to go that way," said W.E. Gates, chairman of Hearing Aids of Roanoke, which owns the Miracle Ear Center. Audiologists' "work is diagnostic," Gates said. "Their background is not trained in the art of fitting hearing aids."
For the first time since the late 1970s, the FDA is strengthening regulations on hearing aids, including endorsement of a requirement that all prospective hearing-aid purchasers be examined by a licensed hearing professional prior to fitting.
The law now requires that consumers undergo a medical examination within six months of the fitting, although many consumers get around that requirement by signing an approved federal waiver.
Because use of the waiver has become so pervasive, the FDA fears that some purchasers are buying hearing aids that do not work or are fitted improperly.
"We are proposing to eliminate that waiver," said Sharon Snider, an FDA spokeswoman. "Many people do choose to waive an exam, and that results in poor fitting and inappropriate hearing aids that end up in somebody's dresser drawer."
A backdrop to this ongoing debate is the FDA's crackdown this summer on misleading advertising by hearing-aid manufacturers and distributors, including false claims that some hearing aids could filter out background noise while improving hearing in noisy environments.
The FDA found no data to back up such claims and sent letters to manufacturers ordering them to pull the advertisements.
Among those receiving warnings were Dahlberg Inc., manufacturer of the Miracle-Ear Clarifier and Micro Elite; Electone Inc.; Siemens Hearing Instruments, manufacturer of LifeSound; Omni Hearing Systems, manufacturer of Enviro 2000; Starkey Laboratories Inc., manufacturer of Secret Ear; Beltone Electronics Corp.; Personal Sound Technologies Inc.; and Resound Corp.
That controversy has heightened the debate and put hearing-aid specialists on the defensive. The American Association of Retired Persons, which also is in the business of dispensing hearing aids, has stepped up the rhetoric by calling for reform.
"It has affected the attitude of the people in the business," said Carl McCurdy, owner of Beltone Hearing Aid Center and an authorized dispenser for Beltone Electronics. "The very fact that the FDA says some of the advertising is improper, it makes you stop and think, `Have I done something incorrectly?' Your approach when working with a hard-of-hearing person is affected slightly."
McCurdy and Gates have been dispensing hearing aids for more than three decades, and both men say Virginia's laws - which include state examination and licensing of those who want to become hearing-aid specialists - could serve as a model for the FDA.
"The hearing specialists lobbied to get the laws on the books," Gates said, "because we knew there was some riff-raff out there."
Gates, a former president of the Virginia Society of Hearing Aid Specialists and member of the state licensing board, said the state has averaged about 12 complaints for 25,000 hearing aids sold each year.
Nevertheless, Whichard believes the far more extensive training that audiologists undergo makes them better suited to conduct a hearing examination.
Audiologists must complete a master's level course of study, participate in an internship and pass a national examination. They also must pass the state exam before dispensing hearing aids.
"We don't have any problem with commercial dealers selling the hearing aids," Whichard said, "but we do think it takes an audiologist to perform the pre-purchase examination."
Whichard will be backed up at today's FDA public hearing in Rockville, Md., by Leslie Adams, the Roanoke mother of two hearing-impaired children.
Audiologists discovered her children's hearing problems after medical doctors found nothing wrong, Whichard said.
"We were put off by our pediatrician," said Adams, who was living in Montgomery County, Md., at the time. Her 17-month-old daughter finally was diagnosed at the University of Virginia with a severely profound loss in one ear and a severe loss in the other.
"Eleven months later, even after my daughter had been diagnosed as deaf, the pediatrician still did no further testing of my son," said Adams, who moved with her family to Roanoke shortly before her son's birth.
Three months later, her son was diagnosed at Children's Hospital of D.C. with a bilaterally severe hearing loss.
"If I have cancer of the liver, I'm not going to go to my general-practice doctor," she said.
Snider, of the FDA, believes his agency will rewrite the regulations to require an examination before a hearing-aid fitting. But the FDA is unlikely to specify who - doctors, audiologists or licensed specialists - should conduct the tests.
"We're proposing that people who are going to buy a hearing aid be examined by a health professional," Snider said. "We are not specifying what kind, but someone who is licensed by the state to do these examinations."
Eventually, McCurdy believes, audiologists will become more and more prominent in the hearing-aid business. In his own company, he employs an audiologist, one of 10 hearing-aid specialists on staff.
"We certainly recognize what the future holds," said McCurdy, who served on the state licensing board between 1980 and 1988. "As time goes on, more and more hearing specialists with audiology education will be involved at the local level."
The FDA hearings are expected to last through Tuesday. Written comments about the proposed regulations will be accepted through Jan. 10.
by CNB