FDA Regulations for HISREBECCA WALDO, HIS

FDA Regulations

Current requirements issued on February 25, 2009. Applies to Hearing Aid Devices and Personal Sound Amplification

Products (PSAPs). Regulations cover device classification, professional title definitions,

requirements for hearing aid purchase, and guidelines for fitting children with hearing aids.

Find the entire document at: http://www.fda.gov/RegulatoryInformation/Guidances/ucm127086.htm.

Medical Evaluation Requirements

Every patient should be encouraged to seek counsel from their physician prior to hearing aid fitting. If the patient is over 18 years old and does not exhibit one of the eight red

flags, they have the option of signing a medical waiver. For persons under the age of 18 years old, a medical clearance from a

physician is required prior to fitting. Children should be encouraged to seek help from an audiologist “…since hearing loss may cause problems in language development and the educational and social growth of the child.” 21CFR801.420

FDA Red Flags

Dispensers are required to refer a patient to a physician prior to fitting if any of the following conditions are observed: Visible congenital or traumatic deformity of the ear. History of active drainage form the ear within the previous 90 days. History of sudden or rapidly progressive hearing loss within the previous 90 days. Acute or chronic dizziness. Unilateral hearing loss of sudden or recent onset within the previous 90 days. Audiometric air-bone gap equal to or greater than 15 decibels at 500Hz, 1,000Hz,

and 2,000Hz. Visible evidence of significant cerumen accumulation or a foreign body in the ear

canal. Pain or discomfort in the ear.

Visible congenital or traumatic deformity of the ear.

Visible traumatic deformity identified. Commonly known as “cauliflower ear”.

Patient would need physician clearance prior to fitting with a hearing aid.

Physician clearance required even if condition is known and old.

History of active drainage form the ear within the previous 90 days.

Active drainage observed. Patient should visit their physician

and obtain medical clearance pre-fitting.

If drainage is ongoing, special considerations for the fitting should be explored.

Sudden Hearing Loss

History of sudden or rapidly progressive hearing loss within the previous 90 days.

Hearing loss will be in both ears. Patient will need to express this

during case history or subsequent conversation.

Unilateral hearing loss of sudden or recent onset within the previous 90 days.

Hearing loss will be in one ear. Patient will need to express this

during case history or subsequent conversation.

Acute or chronic dizziness.

Patient can express this during the case history or subsequent conversations.

The clinician can also observe any problems with dizziness during the appointment. Does the patient have trouble standing and walking? Does the patient get dizzy during procedures? (Otoscopy, impression, hearing evaluation…)

Audiometric air-bone gap equal to or greater than 15 decibels at 500Hz, 1,000Hz, and 2,000Hz. This requirement is observed post

evaluation. Air-bone gap (ABG) should be between air and bone scores of the same ear.

Audiogram example: Indicates a conductive hearing

loss. Can also be observed with mixed hearing losses.

Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.

Observed during otoscopy. Testing can still be completed in

some cases. Headphones vs. earphones? Cerumen management:

Certification and malpractice insurance required.

Pictured: ear ring in ear canal.

Pain or discomfort in the ear.

Patient should communicate this condition during case history and subsequent conversations.

May be noted during physical contact. Is otoscopy painful? Is auditory testing painful?

Physician Referral

Send physician as much information as possible. What conditions did the patient exhibit? What did otoscopy reveal? Results of auditory testing, if completed.

Must have medical information release form signed by patient to send notes. Patient may also take a copy of the appointment notes with them.

Subsequent medical clearance from physician must be returned within 90 days of initial appointment.

Case Study

76 year old woman Came in for routine hearing evaluation. Childhood noise exposure from firecracker going off nearby. Patient noted feeling like there was a sudden loss in her right ear. Otoscopy revealed cerumen impaction in both ears. Proceeded with testing using TDH headphones. Testing performed was

to get a baseline with occlusion. Air conduction only. Patient was instructed that testing was optional and would have to be repeated post cermen removal.

Case Study

Testing revealed asymmetrical loss. Patient referred for:

Significant cerumen Pain Sudden loss in right ear

Patient indicated she would have her physician wash ears and check other issues.

Case Study

Patient returned post ear wash and physician visit.

Complained of severe pain that diminished one day prior.

Otoscopy revealed a clear and healthy right ear. Thresholds improved due to cerumen removal.

Left ear revealed a ruptured ear drum, discharge and blood. Patient did not complain of pain at the current time.

Case Study

What happens next? Patient was tested using TDH headphones to

view hearing loss with the ruptured ear drum. Left ear showed a new, conductive hearing

loss due to missing ear drum. Patient was referred to ENT for air-bone gap

of more than 15dB at 500Hz, 1,000Hz, and 2,000Hz in the left ear, drainage, and pain.

Referral contained notes of trauma to ear drum and drainage.

Case Study

Patient went to ENT, was put on antibiotics and treated for the ruptured ear drum.

ENT had audiogram done again, after healing time had gone by, and patient was happy to hear her hearing levels in her left ear had improved greatly.

Patient called to check in with us, and followed up with a letter detailing her experience and her gratitude for the hearing healthcare afforded to her at OTC.

She is now a supporter of our program and yearly hearing evaluations!

Questions?

Questions concerning appointment, FDA red flags, etc.?

References

Pictures from: Patient files http://www.hawkelibrary.com/ http://answermeup.com/questions/drain-pus-from-ear.html