Week 7 Adult Candidacy Flashcards
1
Q
FDA mission statement
A
- food and drug administration
- mission statement: responsibility of protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biologic products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation
- has 7 total centers:
- –center of devices and radiological health (CDRH)
- —–a branch of the FDA responsible for overseeing medical devices, such as cochlear implants and hearing aids
2
Q
when were the first FDA CIs for adults and children
A
- adults in 1985
* children in 1990
3
Q
how many regulatory classes does the FDA have for medical devices
A
3
4
Q
class 1 devices (FDA)
A
- pose the least amount of risk
- manufacturers must notify the FDA before marketing, registration and listing, prohibitions against adulteration and misbranding, and rules for good manufacturing practices
- hearing aids, power wheelchairs elastic bandages, and otoscopes fall into class 1
- –basically when manufacturers release new HAs they need to notify the FDA who will make sure everything is good and consumers arent being taken advantage of
5
Q
class 2 devices (FDA)
A
- pose moderate safety of risk
- all class 1 requirements apply and this additionally need manufacturers to provide the FDA with premarket notification and performance standards
- BAHA, power wheelchairs, surgical drapes, and x-ray equipment
6
Q
class 3 devices (FDA)
A
- pose high potential risk
- all class 1 and 2 requirements apply and additionally you need premarket approval (PMA)
- –required clinical trials to show what the devices are doing and any side effects
- these are devices that sustain human health
- cochlear implants, ABI, and implantable pacemakers are examples
- –the process for class 3 can take a few years sometimes
7
Q
is the FDA responsible for designing candidacy criteria for CI’s
A
- no the FDA is not responsible for designing candidacy criteria for CIs
- the premarket approval (PMA) application (written by the manufacturer) outlines criteria for the CI used in the trial, the FDA approves or rejects the whole application
- if approved, the candidacy criteria becomes the “FDA Labeled Indications”
8
Q
who does the FDA govern and who do they not
A
- FDA governs the industry
- FDA does not govern the individual clinician nor implant center
- –manufacturers cant talk about things that arent FDA approved, they are not allowed to
- –as a clinician though you have the ability to override the labeled criteria if you can explain why you recommend implantation even if they are for example under 12 months (which is the FDA label criteria)
- —–this is off-label usage
9
Q
cochlear CI label criteria for children
A
- children 12-24 months of age who have bilateral profound SNHL
- children 2+ may demonstrate severe to profound SNHL, bilat
- little benefit from appropriate binaural HAs, defined as:
- –in younger children: lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to 6-mo period. It is recommended that limited benefit be quantified on a measure such as the meaningful auditory integration scale or the early speech perception test
- –on older children: = 30% correct on the open set Multisyllabic Lexical Neighborhood Test or Lexical Neighborhood test, depending upon the child’s cognitive and linguistic skills. A three to six month hearing aid trial is recommended for children without previous aided experience
10
Q
cochlear CI label criteria for adults
A
- individuals 18+ with bilateral, pre, peri, or postlingual SNHL
- limited benefit from appropriate binaural HAs, as defined by test scores of 50% correct or less in the ear to be implanted (60% or less in the best-aided condition) on tape-recorded tests of open set sentence recognition
- moderate to profound HL in the low freq and profound (>/= 90dB HL) in the mid to high speech freqs
11
Q
cochlear hybrid CI label criteria
A
- severe to profound SNHL at freq >/= 1.5kHz (2,3,4k Hz average >/= 75 dB HL)
- hearing at freq = 0.5kHz is 60 dB or better
- CNC is >/= 10% but not better than 60% in the ear being implanted
- contra ear has equal or better CNC score, but not better than 80%
- no conductive HL
- less than 30 yrs duration
12
Q
Med-EL CI label criteria for children
A
*12 months+ who demonstrate profound, bilat, SNHL with thresholds as 90dB or greater at 1000Hz
*lack of hearing aid benefit is defined at:
—in younger children: lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and participation in intensive aural habilitation over a 3-6 month period
—in older children:
<20% correct on the multi-syllabic lexical neighborhood test or lexical neighborhood test, depending upon the child’s cognitive ability and linguistic skills
*a 3-6 mo HA trial is required for children without previous experience with HAs. radiological evidence of cochlear ossification may justify a shorter trial with amplification
13
Q
Med-El CI label criteria for adults
A
- 18+ with bilat SNHL
- limited benefit from appropriately fitted binaural HAs, defined by test scores of 40% correct or less in best aided listening condition on CD recorded tests of open-set sentence recognition (hearing in noise test (HINT) sentences)
- bilat severe to profound SNHL determined by a pure tone average of 70 dB or greater at 500, 1000, and 2000Hz
14
Q
Med-el hybrid CI label criteria
A
- monosyllable score should be =60% at 65 dB SPL in the best aided condition
- –mild to moderate LF SNHL sloping to a profound HL in the HF
- no progressive HL
- no autoimmune diseases
- no HL as a result of meningitis, otosclerosis, or ossification
- no malformations or obstructions of the cochlea
- no air-bone gap>15 dB
- no external ear contraindications to using amplification devices
15
Q
AB CI label criteria for children
A
- 12mo-17yrs
- profound bilat SNHL (>/=90 dB)
- use of appropriately fitted HAs for at least 6 months in children 2-17 yrs of age, or at least 3 months in children 12-23 months of age. minimum duration of HA use is waived if x-rays indicate ossification of the cochlea
- little or no benefit from appropriately fitted HAs, as defined as:
- –in younger kids (<4 yrs) a failure to reach developmentally appropriate milestones (such as spontaneous response to name in quiet or to environmental sound) measured using the infant-toddler meaningful auditory integration scale or meaningful auditory integration scale or <20% correct on a simple open-set word recognition test (MLNT) administered using MLV (70 dB SPL)
- –in older children (4+) scoring <12% on a difficult open-set word recognition test (phonetically balanced-kindergarten test) or <30% in an open-set sentence test (hearing in noise test for children) administered using recorded materials in the soundfield (70dB SPL)
