81 FR 3325 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 13 (January 21, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 13 (January 21, 2016)
| Page Range | 3325-3327 | |
| FR Document | 2016-01090 |
[Federal Register Volume 81, Number 13 (Thursday, January 21, 2016)] [Rules and Regulations] [Pages 3325-3327] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01090] [[Page 3325]] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Identified risks Mitigation methods ---------------------------------------------------------------------------------------------------------------- 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. [[Page 3326]] 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. ---------------------------------------------------------------------------------------------------------------- \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 [[Page 3327]] 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
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DEPARTMENT OF HEALTH AND class I or II, or FDA issues an order classification will be the initial
HUMAN SERVICES finding the device to be substantially classification of the device.
equivalent, in accordance with section On January 5, 2015, EarLens
Food and Drug Administration 513(i), to a predicate device that does Corporation submitted a request for
not require premarket approval. The classification of the EarLensTM Contact
21 CFR Part 874 Agency determines whether new Hearing Device under section 513(f)(2)
[Docket No. FDA–2015–N–4328]
devices are substantially equivalent to of the FD&C Act. The manufacturer
predicate devices by means of recommended that the device be
Medical Devices; Ear, Nose, and Throat premarket notification procedures in classified into class II (Ref. 1).
Devices; Classification of the section 510(k) of the FD&C Act (21 In accordance with section 513(f)(2) of
Tympanic Membrane Contact Hearing U.S.C. 360(k)) and part 807 (21 CFR part the FD&C Act, FDA reviewed the
Aid 807) of the regulations. request in order to classify the device
Section 513(f)(2) of the FD&C Act, as under the criteria for classification set
AGENCY: Food and Drug Administration, amended by section 607 of the Food and
HHS. forth in section 513(a)(1) of the FD&C
Drug Administration Safety and Act. FDA classifies devices into class II
ACTION: Final order. Innovation Act (Pub. L. 112–144), if general controls by themselves are
provides two procedures by which a insufficient to provide reasonable
SUMMARY: The Food and Drug person may request FDA to classify a
Administration (FDA) is classifying the assurance of safety and effectiveness,
device under the criteria set forth in but there is sufficient information to
tympanic membrane contact hearing aid section 513(a)(1). Under the first
into class II (special controls). The establish special controls to provide
procedure, the person submits a reasonable assurance of the safety and
special controls that will apply to the premarket notification under section
device are identified in this order and effectiveness of the device for its
510(k) of the FD&C Act for a device that intended use. After review of the
will be part of the codified language for has not previously been classified and,
the tympanic membrane contact hearing information submitted in the request,
within 30 days of receiving an order FDA determined that the device can be
aid’s classification. The Agency is classifying the device into class III
classifying the device into class II classified into class II with the
under section 513(f)(1) of the FD&C Act, establishment of special controls. FDA
(special controls) in order to provide a the person requests a classification
reasonable assurance of safety and believes these special controls, in
under section 513(f)(2). Under the addition to general controls, will
effectiveness of the device. second procedure, rather than first
DATES: This order is effective January provide reasonable assurance of the
submitting a premarket notification safety and effectiveness of the device.
21, 2016. The classification was under section 510(k) of the FD&C Act
applicable on September 29, 2015. Therefore, on September 29, 2015,
and then a request for classification
FOR FURTHER INFORMATION CONTACT:
FDA issued an order to the requestor
under the first procedure, the person
Cherish Giusto, Center for Devices and classifying the device into class II. FDA
determines that there is no legally
Radiological Health, Food and Drug is codifying the classification of the
marketed device upon which to base a
Administration, 10903 New Hampshire device by adding 21 CFR 874.3315.
determination of substantial
Ave., Bldg. 66, Rm. 2432, Silver Spring, equivalence and requests a classification Following the effective date of this
MD 20993–0002, 301–796–9679, under section 513(f)(2) of the FD&C Act. final classification order, any firm
cherish.giusto@fda.hhs.gov. If the person submits a request to submitting a premarket notification
SUPPLEMENTARY INFORMATION: classify the device under this second (510(k)) for a tympanic membrane
procedure, FDA may decline to contact hearing aid will need to comply
I. Background undertake the classification request if with the special controls named in this
In accordance with section 513(f)(1) of FDA identifies a legally marketed device final administrative order.
the Federal Food, Drug, and Cosmetic that could provide a reasonable basis for The device is assigned the generic
Act (the FD&C Act) (21 U.S.C. review of substantial equivalence with name tympanic membrane contact
360c(f)(1)), devices that were not in the device or if FDA determines that the hearing aid, and it is identified as a
commercial distribution before May 28, device submitted is not of ‘‘low- prescription device that compensates for
1976 (the date of enactment of the moderate risk’’ or that general controls impaired hearing. Amplified sound is
Medical Device Amendments of 1976), would be inadequate to control the risks transmitted by vibrating the tympanic
generally referred to as postamendments and special controls to mitigate the risks membrane through a transducer that is
devices, are classified automatically by cannot be developed. in direct contact with the tympanic
statute into class III without any FDA In response to a request to classify a membrane.
rulemaking process. These devices device under either procedure provided FDA has identified the following risks
remain in class III and require by section 513(f)(2) of the FD&C Act, to health associated specifically with
premarket approval unless and until the FDA will classify the device by written this type of device and the measures
device is classified or reclassified into order within 120 days. This required to mitigate these risks:
TABLE 1—TYMPANIC MEMBRANE CONTACT HEARING AID RISKS AND MITIGATION MEASURES
Identified risks Mitigation methods
jstallworth on DSK7TPTVN1PROD with RULES
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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![Federal Register / Vol. 81, No. 13 / Thursday, January 21, 2016 / Rules and Regulations 3327
demonstrate that the device performs as FOR FURTHER INFORMATION CONTACT: purchase. Establishment of an AVA is
intended under anticipated conditions Karen A. Thornton, Regulations and neither an approval nor an endorsement
of use. Rulings Division, Alcohol and Tobacco by TTB of the wine produced in that
(4) Professional training must include Tax and Trade Bureau, 1310 G Street area.
the ear impression procedure, correct NW., Box 12, Washington, DC 20005;
placement, fitting, monitoring, care, and Requirements
phone 202–453–1039, ext. 175.
maintenance of the device. SUPPLEMENTARY INFORMATION: Section 4.25(e)(2) of the TTB
(5) Labeling must include the regulations (27 CFR 4.25(e)(2)) outlines
following: Background on Viticultural Areas the procedure for proposing an AVA
(i) A detailed summary of the adverse TTB Authority and provides that any interested party
events and effectiveness outcomes from may petition TTB to establish a grape-
the clinical performance testing; Section 105(e) of the Federal Alcohol growing region as an AVA. Section 9.12
(ii) Detailed instructions on how to fit Administration Act (FAA Act), 27 of the TTB regulations (27 CFR 9.12)
the device to the patient; U.S.C. 205(e), authorizes the Secretary prescribes standards for petitions for the
(iii) Instructions for periodic cleaning of the Treasury to prescribe regulations establishment or modification of AVAs.
of any reusable components; for the labeling of wine, distilled spirits, Petitions to establish an AVA must
(iv) Information related to and malt beverages. The FAA Act include the following:
electromagnetic compatibility; and provides that these regulations should, • Evidence that the area within the
(v) Patient labeling that includes: among other things, prohibit consumer proposed AVA boundary is nationally
(A) A patient card that identifies if a deception and the use of misleading or locally known by the AVA name
patient has been fitted with any non- statements on labels and ensure that specified in the petition;
self- removable components of the labels provide the consumer with • An explanation of the basis for
device and provides relevant adequate information as to the identity defining the boundary of the proposed
information in cases of emergency; and quality of the product. The Alcohol AVA;
(B) Information on how to correctly and Tobacco Tax and Trade Bureau • A narrative description of the
use and maintain the device; (TTB) administers the FAA Act features of the proposed AVA affecting
(C) The potential risks and benefits pursuant to section 1111(d) of the viticulture, such as climate, geology,
associated with the use of the device; Homeland Security Act of 2002,
and soils, physical features, and elevation,
codified at 6 U.S.C. 531(d). The that make the proposed AVA distinctive
(D) Alternative treatments.
Secretary has delegated various and distinguish it from adjacent areas
Dated: January 13, 2016. authorities through Treasury outside the proposed AVA boundary;
Leslie Kux, Department Order 120–01, dated • The appropriate United States
Associate Commissioner for Policy. December 10, 2013 (superseding Geological Survey (USGS) map(s)
[FR Doc. 2016–01090 Filed 1–20–16; 8:45 am] Treasury Department Order 120–01, showing the location of the proposed
BILLING CODE 4164–01–P dated January 24, 2003), to the TTB AVA, with the boundary of the
Administrator to perform the functions proposed AVA clearly drawn thereon;
and duties in the administration and and
DEPARTMENT OF THE TREASURY enforcement of these provisions. • A detailed narrative description of
Part 4 of the TTB regulations (27 CFR the proposed AVA boundary based on
Alcohol and Tobacco Tax and Trade part 4) authorizes TTB to establish USGS map markings.
Bureau definitive viticultural areas and regulate
the use of their names as appellations of Los Olivos District Petition
27 CFR Part 9 origin on wine labels and in wine TTB received a petition from C.
advertisements. Part 9 of the TTB Frederic Brander, owner and winemaker
[Docket No. TTB–2015–0004; T.D. TTB–132;
Ref: Notice No. 148] regulations (27 CFR part 9) sets forth of the Brander Vineyard, proposing the
standards for the preparation and establishment of the ‘‘Los Olivos
RIN 1513–AC11 submission of petitions for the District’’ AVA in Santa Barbara County,
establishment or modification of California. There are 12 bonded
Establishment of the Los Olivos American viticultural areas (AVAs) and wineries and approximately 47
District Viticultural Area commercially producing vineyards
lists the approved AVAs.
AGENCY: Alcohol and Tobacco Tax and covering a total of 1,120 acres within the
Definition proposed AVA. The proposed Los
Trade Bureau, Treasury.
ACTION: Final rule; Treasury decision. Section 4.25(e)(1)(i) of the TTB Olivos District AVA shares its western
regulations (27 CFR 4.25(e)(1)(i)) defines boundary with the eastern boundary of
SUMMARY: The Alcohol and Tobacco Tax a viticultural area for American wine as the Ballard Canyon AVA (27 CFR 9.230)
and Trade Bureau (TTB) establishes the a delimited grape-growing region having and its eastern boundary with the
approximately 22,820-acre ‘‘Los Olivos distinguishing features, as described in western boundary of the Happy Canyon
District’’ viticultural area in Santa part 9 of the regulations, and a name of Santa Barbara AVA (27 CR 9.217), but
Barbara County, California. The and a delineated boundary, as it does not overlap either of these AVAs.
viticultural area is located within the established in part 9 of the regulations. It is located within the Santa Ynez
Santa Ynez Valley viticultural area and These designations allow vintners and Valley viticultural area and the larger,
the larger, multicounty Central Coast consumers to attribute a given quality, multicounty Central Coast viticultural
jstallworth on DSK7TPTVN1PROD with RULES
viticultural area. TTB designates reputation, or other characteristic of a area.
viticultural areas to allow vintners to wine made from grapes grown in an area According to the petition, the
better describe the origin of their wines to the wine’s geographic origin. The distinguishing features of the proposed
and to allow consumers to better establishment of AVAs allows vintners Los Olivos District AVA include its
identify wines they may purchase. to describe more accurately the origin of topography, soils, and climate. The
DATES: This final rule is effective their wines to consumers and helps proposed AVA is located on a broad
February 22, 2016. consumers to identify wines they may alluvial terrace plain of the Santa Ynez
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Document Created: 2018-02-02 12:33:46
Document Modified: 2018-02-02 12:33:46
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final order. | |
| Dates | This order is effective January 21, 2016. The classification was applicable on September 29, 2015. | |
| 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] | |
| FR Citation | 81 FR 3325 |
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