The document discusses FDA regulations for hearing aid devices, including requirements for medical evaluations and exceptions. Patients under 18 require physician clearance, while those over 18 can sign a waiver unless they exhibit red flags like drainage, pain, or sudden hearing loss. The regulations also specify referrals for conditions like cerumen impaction or large air-bone gaps. A case study example shows how these rules were applied for a patient with cerumen, pain, and sudden hearing loss who was ultimately referred to an ENT doctor and had a positive outcome.

1. FDA Regulations for HIS
REBECCA WALDO, HIS

2. 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.

3. 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

4. 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.

5. 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.

6. 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.

7. 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.

8. 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…)

9. 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.

10. 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.

11. 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?

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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!

18. Questions?
 Questions concerning appointment, FDA red flags, etc.?

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