[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)]
[Rules and Regulations]
[Pages 3325-3327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01090]
[[Page 3325]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 874
[Docket No. FDA-2015-N-4328]
Medical Devices; Ear, Nose, and Throat Devices; Classification of
the Tympanic Membrane Contact Hearing Aid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the
tympanic membrane contact hearing aid into class II (special controls).
The special controls that will apply to the device are identified in
this order and will be part of the codified language for the tympanic
membrane contact hearing aid's classification. The Agency is
classifying the device into class II (special controls) in order to
provide a reasonable assurance of safety and effectiveness of the
device.
DATES: This order is effective January 21, 2016. The classification was
applicable on September 29, 2015.
FOR FURTHER INFORMATION CONTACT: Cherish Giusto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993-0002, 301-796-9679,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were
not in commercial distribution before May 28, 1976 (the date of
enactment of the Medical Device Amendments of 1976), generally referred
to as postamendments devices, are classified automatically by statute
into class III without any FDA rulemaking process. These devices remain
in class III and require premarket approval unless and until the device
is classified or reclassified into class I or II, or FDA issues an
order finding the device to be substantially equivalent, in accordance
with section 513(i), to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as amended by section 607 of the
Food and Drug Administration Safety and Innovation Act (Pub. L. 112-
144), provides two procedures by which a person may request FDA to
classify a device under the criteria set forth in section 513(a)(1).
Under the first procedure, the person submits a premarket notification
under section 510(k) of the FD&C Act for a device that has not
previously been classified and, within 30 days of receiving an order
classifying the device into class III under section 513(f)(1) of the
FD&C Act, the person requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a premarket
notification under section 510(k) of the FD&C Act and then a request
for classification under the first procedure, the person determines
that there is no legally marketed device upon which to base a
determination of substantial equivalence and requests a classification
under section 513(f)(2) of the FD&C Act. If the person submits a
request to classify the device under this second procedure, FDA may
decline to undertake the classification request if FDA identifies a
legally marketed device that could provide a reasonable basis for
review of substantial equivalence with the device or if FDA determines
that the device submitted is not of ``low-moderate risk'' or that
general controls would be inadequate to control the risks and special
controls to mitigate the risks cannot be developed.
In response to a request to classify a device under either
procedure provided by section 513(f)(2) of the FD&C Act, FDA will
classify the device by written order within 120 days. This
classification will be the initial classification of the device.
On January 5, 2015, EarLens Corporation submitted a request for
classification of the EarLensTM Contact Hearing Device under
section 513(f)(2) of the FD&C Act. The manufacturer recommended that
the device be classified into class II (Ref. 1).
In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed
the request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. FDA
classifies devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use. After review of the
information submitted in the request, FDA determined that the device
can be classified into class II with the establishment of special
controls. FDA believes these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.
Therefore, on September 29, 2015, FDA issued an order to the
requestor classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 874.3315.
Following the effective date of this final classification order,
any firm submitting a premarket notification (510(k)) for a tympanic
membrane contact hearing aid will need to comply with the special
controls named in this final administrative order.
The device is assigned the generic name tympanic membrane contact
hearing aid, and it is identified as a prescription device that
compensates for impaired hearing. Amplified sound is transmitted by
vibrating the tympanic membrane through a transducer that is in direct
contact with the tympanic membrane.
FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks:
Table 1--Tympanic Membrane Contact Hearing Aid Risks and Mitigation Measures
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Identified risks Mitigation methods
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Adverse Tissue Reactions.................... Biocompatibility.
Labeling.
Electromagnetic Incompatibility............. Non-Clinical Performance Testing.
Labeling.
MRI Incompatibility......................... Labeling.
Overheating of Ear Canal or Skin............ Non-Clinical Performance Testing.
Clinical Performance Testing.
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Labeling.
Damage to Eyes from Direct Laser Exposure Labeling.
\1\.
Trauma/Damage to the Ear Canal, Tympanic Non-Clinical Performance Testing.
Membrane, or Middle Ear System.
Clinical Performance Testing.
Training.
Labeling.
Residual Hearing Loss....................... Non-Clinical Performance Testing.
Clinical Performance Testing.
Labeling.
Ear Infections.............................. Clinical Performance Testing.
Labeling.
Vertigo or Tinnitus......................... Clinical Performance Testing.
Labeling.
Dampening of Residual Hearing When the Clinical Performance Testing.
Device is Turned Off.
Labeling.
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\1\ A tympanic membrane contact hearing aid may contain a Class 1 laser product in its removable external
component, which users will remove from their ear when the device is not in use (for example, to sleep or
bathe). When being handled off of the ear, it is possible that the user could look directly at the laser.
Thus, there is a risk of ``damage to eyes from direct laser exposure.'' As mitigation, the user should be
warned in labeling not to look directly into the laser or aim it at their eyes.
FDA believes that special controls, in combination with the general
controls, address these risks to health and provide reasonable
assurance of the safety and effectiveness.
Tympanic membrane contact hearing aids are prescription devices
restricted to patient use only upon the authorization of a practitioner
licensed by law to administer or use the device; see 21 CFR 801.109
(Prescription devices).
Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k), if FDA determines that premarket notification is not necessary
to provide reasonable assurance of the safety and effectiveness of the
device. For this type of device, FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of the device. Therefore, this device type is not
exempt from premarket notification requirements. Persons who intend to
market this type of device must submit to FDA a premarket notification,
prior to marketing the device, which contains information about the
tympanic membrane contact hearing aid they intend to market.
II. Environmental Impact, No Significant Impact
We have determined under 21 CFR 25.34(b) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Paperwork Reduction Act of 1995
This final administrative order establishes special controls that
refer to previously approved collections of information found in other
FDA regulations. These collections of information are subject to review
by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of
information in part 807, subpart E, regarding premarket notification
submissions have been approved under OMB control number 0910-0120, and
the collections of information in 21 CFR part 801, regarding labeling
have been approved under OMB control number 0910-0485.
IV. Reference
The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. DEN150002: De novo Request per 513(f)(2) from EarLens
Corporation, dated January 5, 2015.
List of Subjects in 21 CFR Part 874
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
874 is amended as follows:
PART 874--EAR, NOSE, AND THROAT DEVICES
0
1. The authority citation for 21 CFR part 874 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Add Sec. 874.3315 to subpart D to read as follows:
Sec. 874.3315 Tympanic membrane contact hearing aid.
(a) Identification. A tympanic membrane contact hearing aid is a
prescription device that compensates for impaired hearing. Amplified
sound is transmitted by vibrating the tympanic membrane through a
transducer that is in direct contact with the tympanic membrane.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) The patient contacting components must be demonstrated to be
biocompatible.
(2) Non-clinical performance testing must demonstrate that the
device performs as intended under anticipated conditions of use, and
must include:
(i) Mechanical integrity testing;
(ii) Electrical and thermal safety testing;
(iii) Software verification, validation, and hazard analysis;
(iv) Reliability testing consistent with expected device life;
(v) Electromagnetic compatibility testing; and
(vi) Validation testing of device output and mechanical force
applied to the tympanic membrane in a clinically appropriate model.
(3) Clinical performance testing must characterize any adverse
events observed during clinical use, and
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demonstrate that the device performs as intended under anticipated
conditions of use.
(4) Professional training must include the ear impression
procedure, correct placement, fitting, monitoring, care, and
maintenance of the device.
(5) Labeling must include the following:
(i) A detailed summary of the adverse events and effectiveness
outcomes from the clinical performance testing;
(ii) Detailed instructions on how to fit the device to the patient;
(iii) Instructions for periodic cleaning of any reusable
components;
(iv) Information related to electromagnetic compatibility; and
(v) Patient labeling that includes:
(A) A patient card that identifies if a patient has been fitted
with any non-self- removable components of the device and provides
relevant information in cases of emergency;
(B) Information on how to correctly use and maintain the device;
(C) The potential risks and benefits associated with the use of the
device; and
(D) Alternative treatments.
Dated: January 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01090 Filed 1-20-16; 8:45 am]
BILLING CODE 4164-01-P