**Class II Special Controls Guidance Document: Transcutaneous Air
Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA**

**Document issued on: \[Insert release date of FR Notice\]**

![](media/image1.png){width="0.9631944444444445in"
height="1.0763888888888888in"}

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Devices and Radiological Health**

**Ear, Nose and Throat Devices Branch**

**Division of Ophthalmic, Ear, Nose, and Throat Devices**

**Office of Device Evaluation**

**Preface**

**Public Comment**

> For 90 days following the date of publication in the Federal Register
> of the notice announcing the availability of this guidance, you should
> submit comments and suggestions regarding this document to the Docket
> No. 1414 assigned to that notice, Dockets Management Branch, Division
> of Management Systems and Policy, Office of Human Resources and
> Management Services, Food and Drug Administration, 5630 Fishers Lane,
> Room 1061, (HFA-305), Rockville, MD 20852. We will consider comments
> when determining whether to amend this guidance.
>
> After 90 days following the date of publication in the Federal
> Register of the notice announcing the availability of this guidance,
> you may submit comments and suggestions at any time for Agency
> consideration to Dockets Management Branch. Comments may not be acted
> upon by the Agency until the document is next revised or updated.
>
> For questions regarding the use or interpretation of this guidance
> contact Eric A. Mann, M.D., Ph.D., Ear, Nose and Throat Devices Branch
> at (301) 594-2080 or by email exm@cdrh.fda.gov.

**Additional Copies**

> Additional copies are available from the Internet at:
> <http://www.fda.gov/cdrh/%5Bspecific> address\], or CDRH
> Facts-On-Demand. In order to receive this document via your fax
> machine, call the CDRH Facts-On-Demand system at 800-899-0381 or
> 301-827-0111 from a touch-tone telephone. Press 1 to enter the system.
> At the second voice prompt, press 1 to order a document. Enter the
> document number **1414** followed by the pound sign (#). Follow the
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>
> Table of Contents

1\. Introduction [1](#introduction)

2\. Background [1](#background)

3\. The Content and Format of an Abbreviated 510(k) Submission
[2](#the-content-and-format-of-an-abbreviated-510k-submission)

4\. Scope [4](#scope)

5\. Risks to Health [5](#risks-to-health)

6\. Bench[5](#bench-testing) TESTING [5](#__RefHeading___Toc14861675)

7\. Materials Specification [5](#materials-specification)

8\. Biocompatibility and Sterility [5](#biocompatibility-and-sterility)

9\. Clinical Information [6](#__RefHeading___Toc14861678)

10\. Labeling [8](#labeling)

**Class II Special Controls Guidance Document: Transcutaneous Air
Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA**

***This document is intended to provide guidance. It represents the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind the Food
and Drug Administration (FDA) or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statute and regulations.***

# Introduction

This guidance document was developed as a special controls guidance to
support the classification of the Transcutaneous Air Conduction Hearing
Aid System (TACHAS) into Class II (Special Controls). The device is
intended to compensate for impaired hearing without occluding the ear
canal. It consists of an air conduction hearing aid attached to a
surgically fitted tube system, which is placed through the soft tissues
between the post auricular region and the outer ear canal.

This guidance is issued in conjunction with a Federal Register notice
announcing the classification of the TACHAS.

Following the effective date of this final classification rule, any firm
submitting a 510(k) premarket notification for a TACHAS will need to
address the issues covered in the special controls guidance. However,
the firm need only show that its device meets the recommendations of the
guidance or in some other way provides equivalent assurances of safety
and effectiveness.

# Background

> FDA believes that special controls, when combined with the general
> controls[^1], will be sufficient to provide reasonable assurance of
> the safety and effectiveness of the TACHAS. Thus, a manufacturer who
> intends to market a device of this generic type should (1) conform to
> the general controls of the Federal Food, Drug & Cosmetic Act (the
> Act), including the premarket notification requirements described in
> 21 CFR 807 Subpart E, (2) address the specific risks to health
> associated with the TACHAS identified in this guidance and, (3) obtain
> a substantial equivalence determination from FDA prior to marketing
> the device, unless exempt from the premarket notification requirements
> of the Act (refer to 21 CFR 807.85).

This special controls guidance document identifies the classification
regulation and product code for the TACHAS (Refer to Section 4 --
**Scope)**. In addition, other sections of this special controls
guidance document list the risks to health identified by FDA and
describe measures that, if followed by manufacturers and combined with
the general controls, will generally address the risks associated with
the TACHAS and lead to a timely premarket notification \[510(k)\] review
and clearance. This document supplements other FDA documents regarding
the specific content requirements of a premarket notification
submission. You should also refer to 21 CFR 807.87 and other FDA
documents on this topic, such as the **510(k) Manual - Premarket
Notification: 510(k) - Regulatory Requirements for Medical Devices**,
[http://www.fda.gov/cdrh/manual/510kprt1.html]{.underline}.

Under "**The New 510(k) Paradigm - Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications; Final
Guidance**[^2]," a manufacturer may submit a Traditional 510(k) or has
the option of submitting either an Abbreviated 510(k) or a Special
510(k). FDA believes an Abbreviated 510(k) provides the least burdensome
means of demonstrating substantial equivalence for a new device,
particularly once a special controls guidance document has been issued.
Manufacturers considering modifications to their own cleared devices may
lessen the regulatory burden by submitting a Special 510(k).

**The Least Burdensome Approach**

The issues identified in this guidance document represent those that we
believe need to be addressed before your device can be marketed. In
developing the guidance, we carefully considered the relevant statutory
criteria for Agency decision-making. We also considered the burden that
may be incurred in your attempt to comply with the statutory and
regulatory criteria in the manner suggested by the guidance and in your
attempt to address the issues we have identified. We believe that we
have considered the least burdensome approach to resolving the issues
presented in the guidance document. If, however, you believe that there
is a less burdensome way to address the issues, you should follow the
procedures outlined in the "**A Suggested Approach to Resolving Least
Burdensome Issues**" document. It is available on our Center web page
at:
[[http://www.fda.gov/cdrh/modact/leastburdensome.html]{.underline}](http://www.fda.gov/cdrh/modact/leastburdensome.html).

# The Content and Format of an Abbreviated 510(k) Submission 

An Abbreviated 510(k) submission must include the required elements
identified in 21 CFR 807.87, including the proposed labeling for the
device sufficient to describe the device, its intended use, and the
directions for its use. In an Abbreviated 510(k), FDA may consider the
contents of a summary report to be appropriate supporting data within
the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you
include a summary report. The report should describe how this special
controls guidance document was used during the device development and
testing and should briefly describe the methods or tests used and a
summary of the test data or description of the acceptance criteria
applied to address the risks identified in this guidance document, as
well as any additional risks specific to your device. This section
suggests information to fulfill some of the requirements of 807.87 as
well as some other items that we recommend you include in an Abbreviated
510(k).

> **Coversheet**
>
> The voluntary coversheet should prominently identify the submission as
> an Abbreviated 510(k) and cite the title of this class II special
> controls guidance document.
>
> **Proposed labeling**
>
> Proposed labeling should be sufficient to describe the device, its
> intended use, and the directions for its use. (Refer to Section 10 for
> specific information that should be included in the labeling for
> devices of the types covered by this document.)
>
> **Summary report**

We recommend that the summary report contain:

-   A description of the device and its intended use. We recommend that
    the description include a complete discussion of the performance
    specifications and, when appropriate, detailed, labeled drawings of
    the device. You should also submit an \"indications for use\"
    enclosure.[^3]

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-   A description of device design requirements.

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-   An identification of the Risk Analysis method(s) used to assess the
    risk profile in general as well as the specific device's design and
    the results of this analysis. (Refer to Section 6 for the risks to
    health generally associated with the use of this device that FDA has
    identified.)

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-   Discussion of the device characteristics that address the risks
    identified in this class II special controls guidance document, as
    well as any additional risks identified in your risk analysis.

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-   

-   A brief description of the test method(s) you have used or intend to
    use to address each performance aspect identified in Sections 6 and
    7 of this class II special controls guidance document. If you follow
    a suggested test method, you may cite the method rather than
    describing it. If you modify a suggested test method, you may cite
    the method but should provide sufficient information to explain the
    nature of and reason for the modification. For each test, you may
    either (1) briefly present the data resulting from the test in clear
    and concise form, such as a table, **[or]{.underline}** (2) describe
    the acceptance criteria that you will apply to your test
    results.[^4] (See also 21 CFR 820.30, Subpart C - Design Controls
    for the Quality System Regulation.)

If any part of the device design or testing relies on a recognized
standard, you should include (1) a statement that testing will be
conducted and meet specified acceptance criteria before the product is
marketed, or (2) a declaration of conformity to the standard.[^5]
[Please note that testing must be completed before submitting a
declaration of conformity to a recognized standard]{.underline}. (21 USC
514(c)(2)(B)). For more information refer to the FDA guidance, **Use of
Standards in Substantial Equivalence Determinations; Final Guidance for
Industry and FDA**, <http://www.fda.gov/cdrh/ode/guidance/1131.html>.

If it is not clear how you have addressed the risks identified by FDA or
through your risk analysis, we may request additional information about
aspects of the device's performance characteristics. We may also request
additional information if we need it to assess the adequacy of your
acceptance criteria. (Under 21 CFR 807.87(l), we may request any
additional information that is necessary to reach a determination
regarding substantial equivalence.)

As an alternative to submitting an Abbreviated 510(k), you can submit a
Traditional 510(k) that provides all of the information and data
required under 21 CFR 807.87 and described in this guidance. A
Traditional 510(k) should include all of your methods, data, acceptance
criteria, and conclusions. Manufacturers considering modifications to
their own cleared devices should consider submitting Special 510(k)s.

The general discussion above applies to any device subject to a special
controls guidance document. The following is a specific discussion of
how you should apply this special controls guidance document to a
premarket notification for a TACHAS.

# Scope

The scope of this document is limited to the following devices as
described in 21 CFR 874.3340 (product code: NIX).

The classification identification below identifies the device as it
existed at the time of classification.

> Transcutaneous Air Conduction Hearing Aid System (TACHAS) is a
> wearable sound-amplifying device intended to compensate for impaired
> hearing without occluding the ear canal. The device consists of an air
> conduction hearing aid attached to a surgically fitted tube system,
> which is placed through soft tissue between the post auricular region
> and the outer ear canal.

# Risks to Health

In the table below, FDA has identified the risks to health generally
associated with the use of the TACHAS addressed in this document. The
measures recommended to mitigate these identified risks are given in
this guidance document, as shown in the table below. You should also
conduct a risk analysis, prior to submitting your 510(k), to identify
any other risks specific to your device. The 510(k) should describe the
risk analysis method. If you elect to use an alternative approach to
address a particular risk identified in this guidance document, or have
identified risks additional to those in the guidance, you should provide
sufficient detail to support the approach you have used to address that
risk.

+-----------------------------------+----------------------------------+
| ### **Identified risk             | **Recommended mitigation         |
| ** {#identified-risk .unnumbered} | measures**                       |
+-----------------------------------+----------------------------------+
| Infection/Local Inflammation      | Sections 7, 8, 9, 10             |
+-----------------------------------+----------------------------------+
| Injury to Ear Canal               | 7, 9, 10                         |
+-----------------------------------+----------------------------------+
| Ineffective Amplification         | 6, 9, 10                         |
+-----------------------------------+----------------------------------+

# Bench Testing

[]{#__RefHeading___Toc14861675 .anchor}You should test the
electroacoustic characteristics of the air conduction hearing aid
according to ANSI S3.22: Specification of Hearing Aid Characteristics.
Further, real ear probe microphone testing of the TACHAS should be
evaluated in accordance with ANSI S3.42: Testing Hearing Aids with a
Broad-Band Noise Signal.

#  Materials Specification

We recommend that you include a brief summary of the fatigue testing and
strength test validation of the tube system, including the tube,
coupling mechanism, and hearing aid connection.

###  {#section .unnumbered}

### Biocompatibility and Sterility

All tissue contacting materials should be biocompatible. Further, the
tube should be sterile with a sterility assurance level of 1 x 10^-6^.
We recommend that you evaluate the biocompatibility of all tissue
contacting materials in your device. Please refer to the guidance
document entitled **Blue Book Memo, G95-1, Use of International Standard
ISO-10993, \"Biological Evaluation of Medical Devices Part 1: Evaluation
and Testing\"** <http://www.fda.gov/cdrh/g951.html>. For information
regarding the sterility of components, please refer to **Updated 510(k)
Sterility Review Guidance K90-1; Final Guidance for Industry and FDA,**
<http://www.fda.gov/cdrh/ode/guidance/361.html>.

You should select biocompatibility tests appropriate for tissue and bone
contacting devices intended for long-term implantation. If *identical*
materials are used in a predicate device with the same type and duration
of patient contact, you may identify the predicate device in lieu of
performing biocompatibility testing.

-   

1.  []{#__RefHeading___Toc14861678 .anchor}Clinical Information

In accordance with the Least Burdensome provisions of the FDA
Modernization Act of 1997, the agency will rely upon well-designed bench
and/or animal testing rather than requiring clinical studies for new
devices unless there is a specific justification for asking for clinical
information to support a determination of substantial equivalence.
While, in general, clinical studies will not be needed for most TACHAS,
FDA may recommend that you collect clinical data for a TACHAS with:

-   designs dissimilar from designs previously cleared under a premarket
    notification;

-   new technology, i.e., technology different from that used in legally
    marketed TACHAS devices; or

-   indications for use dissimilar from legally marketed TACHAS devices.

FDA will always consider alternatives to clinical testing when the
proposed alternatives are supported by an adequate scientific rationale.
Please consider contacting the Ear, Nose, and Throat Devices Branch to
discuss any clinical testing before initiating studies.

You should address the above differences with clinical information
obtained from use of your TACHAS in the patient population described in
the "Indications for Use" section of your device labeling. FDA believes
that you should include clinical data on at least 30 patients implanted
with your TACHAS who have been followed for a minimum of 6 months post-
implantation in order to demonstrate that clinical performance will meet
users' needs. We recommend that you also present clinical data on a
subset of these patients who have been followed for a minimum of 1 year
to evaluate longer-term complications with your device (e.g.,
granulation tissue, inflammation). Alternative length of follow-up may
be also considered.

We recommend that you include the following clinical information:

> **Demographic Data**
>
> We recommend that you provide:

-   age

-   sex

-   type and severity of hearing loss.

> **Surgical Complications**
>
> We recommend that you describe all complications (e.g., bleeding, ear
> injury, infection), immediate and late, associated with the surgical
> implantation procedure.
>
> **Other Adverse Events**
>
> We recommend that you describe all adverse events associated with the
> implanted conduction tube. The description should include:

-   type of event

-   known contributing factors (if any)

-   time of the event relative to implantation

-   frequency of the event over time

-   treatment and outcome of the event.

> **Pre- and Post-Operative Audiological Data**
>
> Because the design of TACHAS devices mitigates hearing loss
> differently than air-conduction hearing aids, (i.e., the microphone is
> behind the ear and the system does not occlude the ear canal), we
> recommend that you submit complete audiological data for each subject,
> including preoperative and postoperative audiological assessments and
> hearing aid evaluations. In particular, we recommend that you describe
> and provide the aided performance assessment, including, as
> appropriate:

-   functional gain testing

-   real ear probe microphone testing

-   tolerance levels

-   speech perception measures

-   microphone placement effects of the TACHAS.

If a clinical study is needed to demonstrate substantial equivalence,
i.e., conducted prior to obtaining 510(k) clearance of the device, the
study must be conducted under the Investigational Device Exemptions
(IDE) regulation, 21 CFR 812.[^6] FDA has determined that the TACHAS
addressed by this guidance document is a non-significant risk device,
therefore the study is subject to the abbreviated requirements of 21 CFR
812.2(b).[^7] In addition to the requirements of section 21 CFR
812.2(b), sponsors of such trials must comply with the regulations
governing institutional review boards (21 CFR Part 56) and informed
consent (21 CFR Part 50).

After FDA determines that the device is substantially equivalent,
clinical studies conducted in accordance with the indications reviewed
in the 510(k), including clinical design validation studies conducted in
accordance with the quality systems regulation, are exempt from the
investigational device exemptions (IDE) requirements. However, such
studies must be performed in conformance 21 CFR Part 56 and 21 CFR Part
50.

#  Labeling

The premarket notification should include labeling in sufficient detail
to satisfy the requirements of 21 CFR 807.87(e). The following
suggestions are aimed at assisting you in preparing labeling that
satisfies the requirements of 21 CFR 807.87(e).[^8]

> **Directions for use**
>
> As a prescription device, the TACHAS is exempt from having adequate
> directions for lay use. Nevertheless, under 21 CFR 807.87(e), we
> expect to see clear and concise instructions that delineate the
> technological features of the specific device and how the device is to
> be used on patients. Instructions should encourage local/institutional
> training programs designed to familiarize users who are trained in
> otologic surgery with the features of the device and how to use it in
> a safe and effective manner.
>
> **User Instructional Brochure**
>
> We recommend that the User Instructional Brochure, required under 21
> CFR 801.421, include the following information, in addition to the
> information required under 21 CFR 801.420.
>
> A statement encouraging patients to consider an evaluation of
> conventional hearing aid(s) prior to considering implantation of the
> TACHAS, given the surgical risks and post-operative complications
> associated with the TACHAS.
>
> A detailed explanation of realistic expectations of the TACHAS
> compared to the performance of a conventional hearing aid.
>
> A clear description of the type and frequency of surgical risks, in
> layman's terms, associated with implantation of the TACHAS.
>
> A summary of local inflammatory and infectious complications
> associated with the implanted conducting tube over time. The summary
> should include the type, frequency, treatment, and outcome of these
> complications based on the clinical information gathered in Section 9
> of this document.
>
> Clinical experience to date with the implanted sound conducting tube
> demonstrates the importance of local wound care and personal hygiene
> practices in preventing local infectious and inflammatory
> complications. Therefore, we recommend that you include a detailed
> description of these practices (e.g., cleaning the area with hydrogen
> peroxide, application of antibiotic ointments, hand washing prior to
> tube manipulation) necessary to mitigate these complications. We
> recommend that the User Instructional Brochure also indicate signs and
> symptoms that require consultation with the implanting surgeon (e.g.,
> bleeding, granulation tissue around the tube, any fluid draining from
> the ear, near the tube or from the tube itself).
>
> **Physician Labeling**
>
> We recommend that the physician labeling (Surgeon's Guide) include the
> following information.
>
> The surgeon performing the procedure should have training and
> experience in otologic surgery.
>
> The age, audiological, and health status criteria defining the
> appropriate patient population for fitting with the TACHAS.
>
> A statement recommending that patients be fully informed regarding an
> evaluation of conventional hearing aid(s) prior to considering
> implantation of the TACHAS, given the surgical risks and
> post-operative complications associated with the TACHAS.
>
> A clear description of the type and frequency of surgical risks
> (immediate and delayed) associated with implantation of the TACHAS and
> recommendations to minimize these risks.
>
> A summary of local inflammatory and infectious complications
> associated with the implanted conducting tube over time. The summary
> should include the type, frequency, treatment, and outcome of these
> complications based on the clinical information gathered in Section 9.
>
> Contraindications, e.g., aural keloids, chronic otitis externa.
>
> A clear description of the components of the TACHAS as well as the
> instrumentation used during the insertion procedure.
>
> An illustrated description of the technique for local anesthesia,
> placement of the post-auricular incision, creation of the soft tissue
> tract, sizing of the tube to fit the patient, and insertion of the
> tube.
>
> Instructions for removal of the TACHAS should it be necessary for
> medical reasons or desired by the patient.
>
> Detailed instructions for post-operative care, including recommended
> followup visits, wound dressings, application of topical antibacterial
> agents, and recommendations regarding bathing and hair washing during
> healing of the tract.

Instructions for counseling patients on the importance of ongoing local
wound care and hygiene practices (e.g., cleaning the area with hydrogen
peroxide, application of antibiotic ointments, hand washing prior to
tube manipulation) necessary to mitigate the infectious/inflammatory
complications associated with the implanted sound conducting tube.

[^1]: Because this device meets the definition of a hearing aid, the
    general controls for this device include the Special Requirements
    for Specific Devices described in 21 CFR 801.420 and 801.421.

[^2]: <http://www.fda.gov/cdrh/ode/parad510.html>

[^3]: Refer to
    [http://www.fda.gov/cdrh/ode/indicate.html](http://www.fda.gov/cdrh/ode/indicate.pdf)
    for the recommended format.

[^4]: If FDA makes a substantial equivalence determination based on
    acceptance criteria, the subject device should be tested and shown
    to meet these acceptance criteria before being introduced into
    interstate commerce. If the finished device does not meet the
    acceptance criteria and, thus, differs from the device described in
    the cleared 510(k), FDA recommends that submitters apply the same
    criteria used to assess modifications to legally marketed devices
    (21 CFR 807.81(a)(3)) to determine whether marketing of the finished
    device requires clearance of a new 510(k).

[^5]: See Required Elements for a Declaration of Conformity to a
    Recognized Standard (Screening Checklist for All Premarket
    Notification \[510(K)\] Submissions),
    [http://www.fda.gov/cdrh/ode/reqrecstand.html]{.underline}.

[^6]: Clinical trials are exempt from 21 CFR 801.420 and 21 CFR 801.421.

[^7]: Refer to Blue Book Memorandum entitled "SIGNIFICANT RISK AND
    NONSIGNIFICANT RISK MEDICAL DEVICE STUDIES " at
    <http://www.fda.gov/cdrh/d861.html>.

[^8]: Although final labeling is not required for 510(k) clearance,
    final labeling must also comply with the requirements of 21 CFR 801
    before a medical device is introduced into interstate commerce.
    Because the TACHAS includes an air conduction hearing aid component,
    the labeling must conform to the labeling requirements and
    conditions for sale described in 21 CFR 801.420 and 21 CFR 801.421.
    In addition, final labeling for prescription medical devices must
    comply with 21 CFR 801.109. Labeling recommendations in this
    guidance are consistent with the requirements of part 801.