[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]



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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