SUMMARY OF SAFETY AND EFFECTIVENESS DATA

######## General Information {#general-information .Head-2}

+----------------------------------+-----------------------------------+
| A. Device Generic Name:          | Implantable Middle Ear Hearing    |
|                                  | Device                            |
+----------------------------------+-----------------------------------+
|                                  |                                   |
+----------------------------------+-----------------------------------+
| B. Device Trade Name:            | SOUNDTEC^®^ Direct System^SM^     |
|                                  |                                   |
|                                  | consisting of:                    |
+----------------------------------+-----------------------------------+
|                                  | Direct System Implant Assembly    |
+----------------------------------+-----------------------------------+
|                                  | Direct System Earmold Coil        |
|                                  | Assembly                          |
+----------------------------------+-----------------------------------+
|                                  | Direct System Behind-the-Ear      |
|                                  | Sound Processor Assembly          |
+----------------------------------+-----------------------------------+
|                                  | Surgeon's Set                     |
+----------------------------------+-----------------------------------+
|                                  | Clinician's Set                   |
+----------------------------------+-----------------------------------+
|                                  | User's Set                        |
+----------------------------------+-----------------------------------+
|                                  | Search Coil Set                   |
+----------------------------------+-----------------------------------+
|                                  | Test Coupler Set                  |
+----------------------------------+-----------------------------------+
|                                  |                                   |
+----------------------------------+-----------------------------------+
| C. Applicant's Name And Address: | SOUNDTEC, Inc.                    |
+----------------------------------+-----------------------------------+
|                                  | 2601 Northwest Expressway         |
+----------------------------------+-----------------------------------+
|                                  | Suite 400 West                    |
+----------------------------------+-----------------------------------+
|                                  | Oklahoma City, OK 73112           |
+----------------------------------+-----------------------------------+
| D. Premarket Approval (PMA)      | P010023                           |
|                                  |                                   |
| Application Number               |                                   |
+----------------------------------+-----------------------------------+
| E. Date of Notice of Approval to | September 7, 2001                 |
| the                              |                                   |
|                                  |                                   |
| Applicant                        |                                   |
+----------------------------------+-----------------------------------+

######## II. [Indications for Use]{.underline} {#ii.-indications-for-use .Head-2 .unnumbered}

> The SOUNDTEC^®^ Direct System is indicated for use in adults, 18 years
> of age or older, who have a moderate to severe sensorineural hearing
> loss and desire an alternative to an acoustic hearing aid. Prior to
> receiving the device, it is recommended that an individual have
> experience with appropriately fit hearing aids.

######## III. [Contraindications]{.underline}  {#iii.-contraindications .Head-2 .unnumbered}

> The SOUNDTEC^®^ Direct System is contraindicated for subjects who have
> conductive hearing loss, retrocochlear or central auditory disorder,
> active middle ear infections, tympanic membrane perforations
> associated with recurrent middle ear infections, and disabling
> tinnitus.

######## IV. [Warnings and Precautions]{.underline} {#iv.-warnings-and-precautions .Head-2 .unnumbered}

> The warnings and precautions can be found in the SOUNDTEC^®^ Direct
> System labeling (attached).

######## V. [Device Description]{.underline}  {#v.-device-description .Head-2}

> The SOUNDTEC^®^ Direct System is a partially implantable, middle ear
> hearing device that works on the basic principle of energy
> transformation. Vibrational sound energy, induced by sound pressure,
> can be transformed into electromagnetic energy and conveyed to the
> middle ear's ossicles in this form. Specifically, electromagnetic
> energy vibrates the ossicles of the middle ear that have been coupled
> with a magnetic implant, leading to the perception of sound for the
> hearing impaired user.
>
> The following is a summary of SOUNDTEC^®^ Direct System operation.
> Acoustic sound vibrations are received by the microphone of an
> over-the-ear Sound Processor. The Sound Processor transforms this
> acoustic energy into electrical signals, which are amplified and
> transmitted to the Earmold/Coil Assembly in the ear canal. The
> alternating electromagnetic field of the Earmold/Coil Assembly results
> in attractive and repulsive forces on the magnet implant. The magnet
> implant is coupled with the middle ear ossicles, directly driving the
> ossicles' movement, producing amplified sound perception.

### Device Components {#device-components .Head-3 .unnumbered}

> The SOUNDTEC^®^ Direct System consists of three main components: the
> implant, the Earmold/Coil Assembly (or ECA) and the Sound Processor
> (external amplification system)
>
> 1*.* Implant*:* The permanent magnetic implant directly drives the
> ossicles as it receives electromagnetic energy from the ECA (detailed
> below). The Neodymium-Iron-Boron (Nd~2~Fe~14~B) rare earth magnetic
> implant is attached via a wireform ring to the middle ear ossicles at
> the incudo-stapedial (IS) joint. The magnet is hermetically sealed in
> a 99.3% pure unalloyed titanium canister that meets the ASTM F67-95
> Grade 2 specification for surgical implants. The attachment ring is
> composed of titanium alloy wire, which meets the ASTM F136-96
> specification for surgical implants.

2\. Earmold/Coil Assembly (ECA***)**:* The Earmold/Coil Assembly, or
ECA, fits in the user's ear canal. The ECA transduces electrical signals
electromagnetic energy from the Sound Processor (detailed below) and
creates an alternating electromagnetic field with the magnetic implant.
This electromagnetic field results in attractive and repulsive forces on
the magnetic implant, driving the ossicles that are attached to it via
the wireform ring.

> The ECA consists of two components:
>
> a\. Electromagnetic coil:
>
> The coil is composed of core material (HyMµ "80," Carpenter/Mµ encased
> by #43 copper bondable wire that has been coated with polyurethane.
> The core diameter and length are 1mm and 9.5 mm respectively; the
> total coil diameter and length are 2.24mm and 8mm respectively. The
> resistance of the electromagnetic coil is 40Ωand the inductance is 5.9
> mH.
>
> b\. Earmold/Coil Assembly Casing*:*
>
> The electromagnetic coil is embedded in plasticized Poly Methyl
> Methacrylate, a standard acrylic polymer used in hearing aids
> worldwide. This acrylic casing is obtained from the manufacturer in a
> clear form, which is indicated for medical use. The dimensions of the
> ECA casing are dependent on the size and shape of the user's ear
> canal, determined by a deep ear mold impression of the user's external
> ear and ear canal. Once the impression is taken, the ECA casing is
> molded to match the user's unique ear canal and fitted into the ear
> canal by an audiologist or physician. Note that the ECA casing touches
> external ear and ear canal tissue, and is vented to minimize the
> occlusion effect.
>
> 3\. Sound Processor*:* The Sound Processor rests over the external ear
> and functions to receive and amplify the sound vibrations and
> transform the sound pressure into electrical signals which are
> received by the ECA. The Sound Processor consists of three parts,
> which are housed and attached with commercially available ABS plastic
> components commonly used by the hearing aid industry.
>
> a\. Microphone:
>
> The microphone is capable of, but not limited to, a frequency response
> of 100 Hz ~˜~ 10 kHz.

b\. Preamplifier:

> The Sound Processor employs a dual channel wide-dynamic-range input
> compression system (DynamEQ-II) that separates incoming signals into
> high and low frequency channels which can be independently adjusted
> prior to recombination and amplification.

c.  Power amplifier*:*

> The Class D power amplifier is designed to provide extended battery
> life. Battery current is required to perform at the following levels:
> for reference test position, less than or equal to 1.0 mA; for the
> full VC position, less than or equal to 2.8 mA.
>
> Sound Processor Operation*:* The Sound Processor's output may be
> controlled by the user or audiologist. Users may operate a volume
> control, while audiologists may adjust the Sound Processor's three
> trimmers for high frequency, low frequency, and the threshold knee
> point.
>
> Device Accessories:
>
> Five accessory sets assist in operation and maintenance of the
> SOUNDTEC Direct System device:
>
> 1\. Search Coil Set: The SOUNDTEC Search Coil is an optional device
> that may be used to verify the function of the implant to
> electromagnetic stimulation. This device emits a 2000 Hz
> electromagnetic signal that should be perceived by implanted patients
> as a 2000 Hz tone.
>
> 2\. Test Coupler Set*:* This set contains the SOUNDTEC Test Coupler,
> as well as fitting and testing models of the Sound Processors to aid
> audiologists in assisting patients prior to Direct System fitting, at
> fitting, and during field-testing.
>
> 3\. Surgeon's Set*:* This set contains the stainless steel surgical
> instruments and sterilization tray necessary to perform the
> implantation procedure for the magnetic implant. These non-magnetic
> instruments are comparable to most existing magnetic instrumentation
> used in stapedectomy procedures.
>
> 4\. Clinician's Set*:* This set is used by the audiologist to take the
> deep ear impression of the patient's ear canal for the fitting of the
> ECA. It includes impression material, impression gun and canula
> assemblies, impression oil and materials, batteries and impression
> template and materials.
>
> 5\. User's Set*:* This set is provided to each user for maintenance of
> the external portions of the system. It includes a drying agent,
> cleaning spray, batteries, and storage pouch.

######## VI. [Alternative Practices and Procedures]{.underline} {#vi.-alternative-practices-and-procedures .Head-2 .unnumbered}

> Alternative practices and procedures available to SOUNDTEC^®^ Direct
> System users include acoustic hearing aids and other implantable
> middle ear hearing devices. Hearing aids can be worn in a variety of
> styles including behind-the-ear, in-the-ear, in-the-canal, or
> completely-in-the-canal.

######## VII. [Marketing History]{.underline} {#vii.-marketing-history .Head-2 .unnumbered}

> The SOUNDTEC® Direct System has not been marketed in the United States
> or any foreign country.

######## VIII. [Potential Adverse Effects of the Device on Health]{.underline} {#viii.-potential-adverse-effects-of-the-device-on-health .Head-2 .unnumbered}

> Surgery of the middle ear requires manipulation of the ossicular bones
> (malleus, incus, and stapes) and exposes the inner ear to the risk of
> surgical trauma. Serious complications may arise either during or
> after surgery that may include, but are not limited to: sensorineural
> or conductive deafness due to trauma during surgery; granular
> inflammatory lesions; device displacement after surgery due to
> development of scar tissue; damage to the incus; non-functioning
> implant; and infection after surgery. Additional surgery may be
> required to correct these conditions, if possible.
>
> There may also be numbness, swelling or discomfort around the ear, the
> possibility of facial paresis, and/or the disturbance of balance or
> taste, but they are usually transient and resolve within a few weeks
> after surgery.
>
> Refer to Table I, Summary of Adverse Events Reported.

IX\. [Summary of Preclinical Studies]{.underline}

> The objective of the preclinical studies was to provide reasonable
> assurance of the safety of the SOUNDTEC^®^ Direct System prior to
> clinical testing. In addition, the sponsor provided a Declaration of
> Conformity to the following consensus standards:

## Table 1 - Consensus Standards

  ----------------------------------------------------------------------------
  **Title of Standard**     **Standard ID** **Date**    **Agency**
  ------------------------- --------------- ----------- ----------------------
  **Metals**                                            

  Standard Specifications   ASTM F67-95     1995        American Society of
  for Unalloyed Titanium                                Testing of Material
  for Surgical Implant                                  
  Applications                                          

  Standard Specifications   ASTM F136-98    1998        American Society of
  for Wrought Titanium-6                                Testing of Material
  Aluminum-4 Vanadium ELI                               
  (Extra Low Interstitial)                              
  Alloy (UNS R56401) for                                
  Surgical Implant                                      
  Applications                                          

  **Biological and                                      
  Sterilization**                                       

  Biological Evaluation of  ISO 10993-5;    1993        International
  Medical devices---Part 5: 1993                        Organization for
  Tests for *in vitro*                                  Standardization
  cytotoxicity                                          

  Biological Evaluation of  AAMI; 1997      1997        American Association
  Medical Devices, Volume 4                             for Medical
                                                        Instrumentation

  Biological Evaluation of  ISO 10993-10;   1995        International
  Medical Devices---Part    1995                        Organization for
  10: Tests for Irritation                              Standardization
  and Sensitization                                     

  Biological Evaluation of  ISO 10993-7     1995        International
  Medical Devices---Part 7:                             Organization for
  Ethylene Oxide                                        Standardization
  Sterilization Residuals                               

  Rabbit Pyrogen Test       USP XXIV        1/2000      US Pharmacopia

  Sterility Testing/Direct  USP XXII; XXI   1985        US Pharmacopia
  Transfer to Test Media                                

  Cytotoxicity-Elution      USP XXIV        1/2000      US Pharmacopia
  Testing                                               

  **FMEA/Risk Analysis**                                

  Medical Devices---Risk    EN 1441         10/1997     European Committee for
  Analysis                                              Standardization

  Analysis Techniques for   CEI/IEC 812     1985        International
  System                                                Electrotechnical
  Reliability---Procedure                               Commission
  for Failure Mode and                                  
  Effects Analysis (FMEA)                               

  **Engineering**                                       

  Procedure 1A-Performance  ISTA Procedure  7/2000      International Safe
  Test for Individually     1A                          Transit Association
  Packaged-Products                                     (ISTA)
  Weighing 150 lb. (68kg)                               
  or Less                                               

  Method 1014.10 Seal       Mil Std -- 883D 3/1995      United States
                                                        Department of Defense

  Environmental Testing     IEC 68-2-61,    1991        International
  Part 2: Test Z/ABDM       Environmental               Electrotechnical
  Climatic Sequence         Testing Part 2:             Commission
                            TestZ/ABDM:                 
                            Climatic                    
                            Sequence                    

  Basic Environmental       IEC 68-2-32     1975        International
  Testing Procedures Part                               Electrotechnical
  2: Tests                                              Commission

  Medical Electrical        EN 60601-1-2;   1993        European Committee for
  Equipment---Part 1:       1993                        Standardization
  General Requirements for                              
  Safety                                                

  Limits and Methods of     EN 55011 Class  1997        European Committee for
  Measurement of Radio      B Group 1                   Standardization
  Disturbance                                           
  Characteristics of                                    
  Industrial, Scientific,                               
  and Medical (ISM)                                     
  Radio-Frequency Equipment                             
  ----------------------------------------------------------------------------

###  Biocompatibility {#biocompatibility .Head-4}

1\. Direct System Implant

> All body-contacting materials in the implant have been chosen for
> their acceptability in other implantable medical devices. Each
> material has shown a well-characterized level of biological response
> to long-term clinical use.
>
> The SOUNDTEC^®^ Direct System implant consists of a rare earth magnet
> encapsulated in a hermetically sealed titanium canister, which is
> implanted on the incudo-stapedial (IS) joint of the middle ear. The
> canister material and wire form attachment ring is constructed of
> titanium specifically used for surgical implant applications.

2\. Direct System Earmold/Coil Assembly

> A series of *in vitro* and *in vivo* studies were performed on the
> acrylic material of the Earmold/Coil assembly to demonstrate that the
> materials were biocompatible. All testing was conducted in conformance
> with 21 CFR 58 -- *Good Laboratory Practice for Nonclinical Laboratory
> Studies.*
>
> The Earmold/Coil Assembly is a custom made device, which is molded in
> the shape of the subject's external ear and ear canal. It is inserted
> and fitted into the subject's ear canal.
>
> The Earmold/Coil Assembly incorporates standard acrylic polymers,
> which are used in every day hearing aid applications worldwide. This
> is a methacrylate mixture which is indicated for medical use.
>
> The materials were tested in final finished form and passed the
> following tests: Cytotoxicity, Sensitization, and Irritation.

3\. Direct System Sound Processor

> A series of *in vitro* and *in vivo* studies were conducted on the
> medical grade ABS plastic and other material of the Sound Processor to
> demonstrate that the materials were biocompatible. All testing was
> conducted in conformance with 21 CFR 58 -- *Good Laboratory Practice
> for Nonclinical Laboratory Studies.*
>
> The materials were tested in final finished form and passed the
> following tests: Cytotoxicity, Sensitization, and Irritation.

Biocompatibility Conclusion

> The test results showed no acute toxicological concerns and support
> the safety of the SOUNDTEC^®^ Direct System for its intended use.

### B. Microbiology {#b.-microbiology .Head-4 .unnumbered}

> Testing consisting of the sterility assurance of the sterilization
> process, ethylene oxide sterilization residual, and pyrogenicity
> determination were performed on the Direct System. All testing passed
> appropriate International standards.

### C. Mechanical Testing {#c.-mechanical-testing .Head-4 .unnumbered}

> The SOUNDTEC^®^ Direct System was mechanically tested to verify the
> design criteria and device performance with respect to the device's
> properties and specifications in supporting the safety and
> effectiveness of its profile. Where applicable, test protocols were
> written to recognized, consensus standards. Other test protocols were
> drafted to verify design criteria and device performance unique to the
> SOUNDTEC^®^ Direct System as necessary.

> 1\. Direct System Implant

> The Direct System implant was tested in final finished form and passed
> testing for: hermeticity and weld evaluation, magnet-wireform
> separation test, wireform cycle test and wireform implant deflection
> test.

> 2\. Direct System Earmold/Coil Assembly

> The Direct System Sound Processor was tested in finished form and
> passed testing for: environmental testing, shock and vibration testing
> and life expectancy tests.

> 3\. Direct System Sound Processor

> The Direct System performance was evaluated at various input levels
> over the frequency range of 125 Hz to 8000 Hz. This evaluation showed
> that the Sound Processor provides flexibility and smooth transition
> across the range of values for each control and adequate compensation
> across the frequency range.

###  Electrical Testing {#electrical-testing .Head-4}

> The SOUNDTEC^®^ Direct System was electrically tested to verify the
> design criteria and device performance with respect to the device's
> properties and specifications in supporting the safety and
> effectiveness of its profile. Where applicable, test protocols were
> written to recognized consensus standards. Other test protocols, were
> drafted to verify design criteria and device performance unique to the
> SOUNDTEC^®^ Direct System as necessary

> 1\. Direct System Implant

> Where appropriate, the Direct System implant was tested in final
> finished form and passed testing for: Electromagnetic Immunity,
> Electromagnetic Emissions, and Wireless Device Compatibility Tests.
>
> SOUNDTEC^®^ commissioned an independent laboratory to evaluate the
> electrical safety of the Direct System. The laboratory tested the
> Direct System to EN 60601-1-2 and EN55011 and determined that it was
> free from safety hazards and in compliance with requirements of the
> standards.
>
> The evaluation of the SOUNDTEC^^ Direct System for compatibility with
> digital cell phones, theft detecting devices, and metal detectors,
> showed that the sound processor demonstrated a good degree of immunity
> to electromagnetic interference. The initial investigation indicates
> that exposure to magnetic fields that could be experienced in the
> everyday environment generally do not create distorted or abnormal
> output from the sound processor. Also it was determined that the
> SOUNDTEC^^ Direct System does not adversely affect the theft
> detection devices tested.
>
> The ability to hear clearly on a digital cell phone does appear to be
> dependent on the type of phone used, as well as, the positioning of
> the cell phone antenna to the sound processor body. In most cases it
> was found that the use of the digital cell phone did not distort the
> sound quality presented to the user.
>
> 2\. Direct System Earmold/Coil Assembly
>
> Where appropriate, the Direct System Earmold/Coil Assembly was tested
> in final finished form and passed testing for: Electromagnetic
> Immunity, Electromagnetic Emissions, and Wireless Device Compatibility
> Tests.

3.  Direct System Sound Processor

> Where appropriate, the Direct System Sound Processor was tested in
> final finished form and passed testing for: Electromagnetic Immunity,
> Electromagnetic Emissions, and Wireless Device Compatibility Tests.

### Failure Mode Effects Analysis (FMEA)/Hazard Analysis/Failure Rate Prediction {#failure-mode-effects-analysis-fmeahazard-analysisfailure-rate-prediction .Head-4}

> FMEA was evaluated to the component and process levels of the implant,
> Sound Processor and the Earmold/Coil Assembly. The evaluation extended
> to incorporate degree of severity of the consequences, likelihood of
> occurrence, and their detectability. Failure rate was calculated for
> the Sound Processor to be 1.92 x 10^7^ Hours and the Earmold/Coil
> Assembly was calculated to be 3.96 x 10^7^ Hours.
>
> The risk analysis procedure incorporated the requirements of European
> standard EN 1441. The analysis includes identification of each hazard,
> causes, effects, probability of failure, criticality determination,
> acceptability of risk, and (remarks) mitigation. It was determined
> that all stated risks and hazards were acceptable.

###  Life Testing {#life-testing .Head-4}

> A series of *in vitro* were performed on the Direct System under
> accelerated vibrational conditions of 125 dB and 2000Hz, simulating a
> loud aggressive sound. In addition, real time shelf life studies were
> conducted on finished Direct System implants in their final packaging
> configuration.
>
> 1\. Accelerated Life Testing
>
> Accelerated life testing of vibrational conditions of 125 dB and
> 2000Hz was conducted on the Direct System implant. The results showed
> no signs of degradation after 1500 hours of continuous operation.
>
> 2\. Shelf Life Testing
>
> SOUNDTEC^®^ Direct System Implant is packaged in a polyethylene foam
> shield which is placed inside a polyethylene teraphtalate glycol
> (PETG) modified blister tray. The PETG tray is sealed with a Tyvek
> lid/label. The Tyvek tray assembly with the implant and foam are
> placed inside a Tyvek Mylar pouch and is sealed with a Chevron seal.
>
> The testing standards used were USP. Samples analyzed for testing were
> selected on the basis of real-time aging for shelf life. Accelerated
> testing was not used.
>
> Test results demonstrated packaging integrity of 60 months of shelf
> life.
>
> ISTA (International Safe Transit Association) packaging tests were
> performed to determine the ability of SOUNDTEC^®^ packaging to protect
> the product during shipping and handling. Test results showed less
> than 10 % package degradation as allowed in the ISTA project 1A
> specification.

###  MRI Testing {#mri-testing .Head-4}

> Temporal bone studies and Finite Element Analysis (FEA) performed for
> SOUNDTEC^®^ demonstrates that the SOUNDTEC^®^ Direct System implant is
> not affected by the magnetic fields generated by MRI instruments. In a
> 0.3 Tesla Open MRI unit the forces seen by the implant were 20% of the
> forces reported for the closed MRI, which showed a force of 0.74 gms.
>
> Analysis of induction heating resulted in a value of 2.9 x 10^-2^ K
> temperature rise for a 10-minute exposure in a 2 T field.
>
> For a field gradient as high as 3T/mm, linear forces would be
> approximately 1 gm. For a 1.5 Tesla MRI the torsional forces would be
> approximately 50 g-cm. The torsional forces are approximately 23%
> below the force required to damage the I.S. joint.
>
> As animal/clinical testing has not been conducted, SOUNDTEC warns
> users against undergoing a MRI examination, entering a room where MRI
> exams are performed, or come into close proximity to other sources of
> strong magnetic fields

###  Accessory Testing {#accessory-testing .Head-4}

> The search coil is the device used to determine the general location
> of the implant relative to the tympanic membrane surface. It provides
> evidence the implant can be activated electromagnetically. The
> information gained through a search coil examination provides a
> landmark to align the coil when fabricating the Earmold/Coil Assembly.
>
> The test coupler is a device that is used to test the Sound Processor
> and Earmold/Coil Assembly in the same way that hearing aids are tested
> using a hearing aid analyzer.
>
> The Search Coil was found to be an acceptable instrument to locate and
> to determine alignment of the implant. Failure rate for the Search
> coil was calculated to be 4.88 x 10^6^ Hours and the Test Coupler 4.49
> x 10^7^ Hours.

### Software Verification/Validation and Statement Regarding Year 2000 Compliance {#software-verificationvalidation-and-statement-regarding-year-2000-compliance .Head-4}

> The SOUNDTEC^®^ Direct System is not software driven.

###  Animal Studies {#animal-studies .Head-4}

> For purposes of evaluation, an animal test was conducted with the
> SOUNDTEC^®^ Direct System in guinea pigs to establish the safety of
> the device while residing in the middle ear.
>
> The Direct System was simulated in the animal model with a
> proportionately comparable 24 kt gold Implantable Hearing Device (IHD)
> prosthesis. The response of the guinea pig incus to the prosthesis was
> examined at 3 and 6 months post implant.
>
> The results showed no adverse effects associated with the implant.
> Histological analysis showed no evidence of inflammatory response,
> excess middle ear fluid, and erosion of the bone in the
> incudo-stapedial area.
>
> The evidence from this animal study results is consistent with a claim
> of safety as there were no notable histopathology.

### Conclusions of Preclinical Studies {#conclusions-of-preclinical-studies .Head-3 .unnumbered}

The results of the preclinical studies provided reasonable assurance
that the SOUNDTEC® Direct System was safe for clinical studies and
implantation in humans for its intended use.

######## X. [Summary of Clinical Studies]{.underline} {#x.-summary-of-clinical-studies .Head-2 .unnumbered}

###  Study Objectives {#study-objectives .Head-3}

> The study objectives were to determine whether the SOUNDTEC® Direct
> System provided a level of useful sound perception (functional gain)
> and improved subject's satisfaction (self-assessment questionnaires)
> without having a clinically significant affect upon the patient's
> residual hearing (air-conduction thresholds).

The study hypotheses represent primary and secondary study objectives.
The primary objective is addressed by a quantitative endpoint measure,
which provides objective criteria for evaluating the study hypotheses.
Secondary objectives are addressed with objective and descriptive
statistical methods that evaluate the risks and benefits of the device.
Endpoint measures are intended to support specific claims of safety and
efficacy.

###  Study Design {#study-design .Head-3}

> The clinical study was designed as a single-subject, repeated measures
> investigation in which each subject served as her or his own control.
> The study methods applied a variety of standard, well-known and
> accepted audiologic measurement techniques.
>
> Phase II of the study has been conducted as a multi-center prospective
> trial comparing subjects\' aided pre-implant hearing aid (PHA) to the
> SOUNDTEC Direct System.
>
> The investigation involves pre-treatment assessment, implant
> intervention, healing, and post treatment evaluation for each subject
> as follows:
>
> [COURSE OF STUDY]{.underline} [TIME LINE]{.underline}
>
> PRE TREATMENT Week 1-2
>
> Medical and Audiometric Evaluation
>
> Post informed consent waiting period
>
> IMPLANT INTERVENTION Week 3
>
> POST IMPLANT HEALING PERIOD Week 3-13
>
> SOUND PROCESSSOR FITTING Week 13
>
> ACCOMMODATION PERIOD Weeks 13-23
>
> POST TREATMENT EVALUATION Weeks 23-24
>
> LONG TERM FOLLOW UP Post Approval
>
> (36 and 52 weeks)
>
> This investigation\'s primary comparisons were made at approximately
> 20 weeks post implant. Long-term (post approval) follow-up data will
> be obtained at approximately 36 and 52 weeks post implant. Those
> subjects who fit the eligibility criteria and consented to participate
> in the study were consecutively enrolled into the study, regardless of
> gender or ethnic origin. Analysis and statistical comparisons of
> outcomes between baseline and 20 weeks later was used as the basis for
> determining the safety of Direct System, and for determining
> quantitative differences in the efficacy of Direct System compared to
> the PHA.

###  Study Population {#study-population .Head-3}

> A total of one hundred--three (103) subjects with moderate to severe
> sensorineural hearing loss were implanted with the Direct System at
> ten (10) implanting sites, described below:
>
> Implanting Site Locations

+-----------------------------------+----------------------------------+
| Site Location                     | Number of                        |
|                                   |                                  |
|                                   | Subjects                         |
+-----------------------------------+----------------------------------+
| Integris Baptist Medical Center;  | 20                               |
| Oklahoma City, OK                 |                                  |
+-----------------------------------+----------------------------------+
| University of Washington;         | 9                                |
| Seattle, WA                       |                                  |
+-----------------------------------+----------------------------------+
| Dartmouth Hitchcock Medical       | 17                               |
| Center; Lebanon, NH               |                                  |
+-----------------------------------+----------------------------------+
| University of Texas Medical       | 2                                |
| Branch; Galveston, TX             |                                  |
+-----------------------------------+----------------------------------+
| Memphis Surgery Center; Memphis,  | 17                               |
| TN                                |                                  |
+-----------------------------------+----------------------------------+
| University of Texas Southwestern  | 6                                |
| Medical Center; Dallas, TX        |                                  |
+-----------------------------------+----------------------------------+
| Fairview University Medical       | 5                                |
| Center; Minneapolis, MN           |                                  |
+-----------------------------------+----------------------------------+
| Marshfield Clinic; Marshfield, WI | 9                                |
+-----------------------------------+----------------------------------+
| Presbyterian Medical Center       | 7                                |
| Albuquerque, NM                   |                                  |
+-----------------------------------+----------------------------------+
| Wake Forest University, Winston   | 11                               |
| Salem, NC                         |                                  |
+-----------------------------------+----------------------------------+
| Total                             | 103                              |
+-----------------------------------+----------------------------------+

> The majority of subjects in the study were male (68 of 103 or 66%).
> The average age was 65.1 years (median 67.0 years). The average
> duration of hearing loss was 15.4 ± 10.8 years. The etiology of
> hearing loss was unknown for most (51 of 103 or 50%) of the group,
> while noise (31 of 103 or 30%) was the second leading cause of hearing
> loss in the study population. The right ear was chosen for implant in
> a large number (62 of 103 or 60%) of the cases. Nearly all of the
> subjects (88 of 103 or 85%) were binaural hearing aid users. In
> addition, the study subjects have been hearing aid users for an
> average of 7.1 years while the average time of use of the baseline
> hearing aid was 3.7 years.

###  Study Period {#study-period .Head-3}

> The Investigational Device Exemption (IDE) was approved in January
> 1998 under G970299. The investigation consisted of two phases with
> Phase I (Pilot study) including five (5) subjects implanted at one
> site. Enrollment in the pivotal multi-center study began in March 1999
> and included one hundred three (103) subjects implanted in ten (10)
> centers throughout the United States.
>
> Ninety-five of the 103 subjects (92%) have completed the 20-week
> assessment as of April 2001. Thirty-three of the 95 subjects (35%)
> that completed the 20-week follow-up have also completed their 36-week
> assessment testing. In addition, 12 of the 95 subjects (13%) have
> completed their 52-week follow-up.

###  Inclusion and Exclusion Criteria {#inclusion-and-exclusion-criteria .Head-3}

### Inclusion Criteria: {#inclusion-criteria .Head-3 .unnumbered}

-   Bilateral symmetrical sensorineural hearing loss (high frequency
    pure tone average (HFPTA) of 1000, 2000, 4000 Hz within 15 dB of
    each other)

-   Conformance with audiometric threshold profile

> Audiometric Inclusion Criteria

  ------------------------------------ ----------------------------------
  **Frequency (Hz)**                   **Loss (HL-dB)**

  250                                  0-50

  500                                  0-60

  1000                                 10-70

  2000                                 35-75

  3000                                 50-75

  4000                                 50-80

  6000                                 40-100
  ------------------------------------ ----------------------------------

-   Bone conduction audiometric thresholds within 10 dB of air
    conduction thresholds

-   High frequency pure tone average (HFPTA = average of 1000,

-   2000, and 4000 Hz) of 35-70dB HL

-   Score of ≥ 60% on NU-6 words under headphones bilaterally

-   Duration of hearing loss ≥ 2 years without fluctuation

-   Subjects will have at least six months of recent hearing aid use

-   Subjects will have at least 45 days of recent use of NAL-R compliant
    hearing aid

-   21-80 years of age

-   Absence of otitis media, external otitis or retrocochlear pathology

-   Subjects will have sufficient cognitive and English language skills
    and motivation to comply with the study protocol.

-   Subjects will have adequate ear canal size to accommodate
    Earmold/Coil Assembly

-   Dissatisfied hearing aid user

-   Signed Subject Informed Consent Form

### Exclusion Criteria {#exclusion-criteria .Head-4 .unnumbered}

-   Malformation or inflammation of the external and/or middle ear

-   Perforated tympanic membrane

-   Acute otitis media

-   Otosclerosis

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-   Previous middle ear surgery that has destroyed the IS joint or the
    integrity of the ossicular chain

-   Disabling tinnitus

-   Medical condition which affects healing or may have an associated
    hearing loss

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-   Retrocochlear hearing loss

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-   Asymmetrical hearing loss (difference in HFPTA of 1000, 2000, and
    4000Hz of greater than 15dB)

-   Conductive hearing loss

-   Fluctuating hearing loss

-   Unilateral hearing loss

-   Hearing loss duration of less than 2 years

-   Threshold responses outside the audiometric threshold profile
    defined for the study

-   Score of less than 60% on NU 6 (50) words under headphones

-   Personal hearing aid use of less than 6 months

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-   Personal hearing aid does not meet study's NAL-R criteria

-   Age less than 21 years and older than 80 years

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-   Use of NAL-R compliant hearing aid for less than 45 days

-   Satisfied hearing aid wearer

-   Inadequate ear canal size to accommodate Earmold/Coil Assembly

-   Refusal to comply with monaural use requirements of the study
    protocol

-   Insufficient cognitive skills, motivation or English language skills
    to comply with study protocol

###  Findings {#findings .Head-3}

### 1. Safety {#safety .Head-4 .unnumbered}

> The primary outcome for measuring safety was the effect of the device
> on residual hearing. In addition safety was evaluated in terms of the
> incidence of anticipated adverse events, and implant device failures
> and revisions.
>
> One hundred-three (103) subjects underwent the implant procedure with
> the SOUNDTEC^®^ Direct System implant. The following clinical study
> summary is based on ninety-five (95) subjects who had completed
> 20-week assessments. The assessment compared preoperative results with
> an optimally fit acoustic hearing aid in the ear to be implanted to
> post operative results with the SOUNDTEC^®^ Direct System. "Optimally
> fit" as defined by the clinical study included insertion gain matching
> using National Acoustic Laboratories-Revised (NAL-R) prescriptive
> target ranges (±5 dB for 500, 1000, and 2000 Hz and ± 12 dB for 3000
> and 4000 Hz) and evidence of improvement in aided benefit.
>
> Subjects were tested to find hearing thresholds, sound field
> thresholds, speech testing in quiet and noise, aided benefit, and
> subject perceptions.
>
> A. Residual Hearing
>
> 1\. Air Conduction Thresholds
>
> For most subjects (85 of 95 or 89.5%), residual hearing with the
> Direct System was not significantly affected. Average decrease in air
> conduction thresholds at 20 weeks was 4.2 dB across the frequency
> range of 250 to 8000 Hz. Average bone conduction thresholds decreased
> by 1.1 dB. Few subjects (10 of 95 or 10.5%) had greater than 10 dB of
> change. Eight of 95 subjects (8%) experienced a change between 10 to
> 15 dB in hearing thresholds and 2 of 95 subjects (2%) experienced a
> change greater than 15 dB.
>
> Refer to Figure 1.
>
> ![](media/image1.wmf)

2.  Bone Conduction Thresholds

> Figure 2 shows the bone conduction thresholds over the audiometric
> frequency range (250-4000 Hz) for the pre-implant and 20 week
> post-implant conditions. The average changes across these frequencies
> post-implant compared to the pre-implant condition are 1.1 dB. Most
> subjects (91 of 95 or 96%) showed less than an average of 10 dB of
> change in bone conduction thresholds. Few (4 of 95 or 4%) showed an
> average decrease between 10-15 dB of change. No subjects showed
> greater than 15 dB of change for bone conduction thresholds.

![](media/image2.wmf)

> B. Adverse Events Related to the Device

> 1\. Summarized in Table 1 are the adverse events reported on a total
> of 103 subjects reported as of April 4, 2001.
>
> Four (4) subjects were reported as having serious adverse events, all
> of which were determined by a physician to be "definitely" unrelated
> to the device. The events included a cardiovascular disorder,
> carcinoma, and two (2) deaths.

**Table 1. Adverse Events Reported**

(n=103 Subjects)

+----------------------------------------------+-----------+-----------+
| # Description                                | **No.**   | # No.     |
|                                              |           |           |
|                                              | **R       | **R       |
|                                              | eported** | esolved** |
+----------------------------------------------+-----------+-----------+
| Abnormal Ear Sensation^1^                    | 1         | 1         |
+----------------------------------------------+-----------+-----------+
| Device Noise/Electromagnetic Interfence^2^   | 15        | 12        |
+----------------------------------------------+-----------+-----------+
| Ear Disorder^3^                              | 1         | 1         |
+----------------------------------------------+-----------+-----------+
| Ear Mold Assembly Failure^4^                 | 7         | 7         |
+----------------------------------------------+-----------+-----------+
| Ear Pain^5^                                  | 30        | 28        |
+----------------------------------------------+-----------+-----------+
| Increased Hearing Loss^6^                    | 1         | 0         |
+----------------------------------------------+-----------+-----------+
| Hematoma Ear^7^                              | 9         | 9         |
+----------------------------------------------+-----------+-----------+
| Infection^8^                                 | 4         | 4         |
+----------------------------------------------+-----------+-----------+
| Outer Ear Irritation^9^                      | 14        | 14        |
+----------------------------------------------+-----------+-----------+
| Paresthesia^10^                              | 1         | 1         |
+----------------------------------------------+-----------+-----------+
| Processor Failure^11^                        | 13        | 12        |
+----------------------------------------------+-----------+-----------+
| Skin Irritation^12^                          | 3         | 3         |
+----------------------------------------------+-----------+-----------+
| Taste Perversion^13^                         | 3         | 2         |
+----------------------------------------------+-----------+-----------+
| Tinnitus^14^                                 | 1         | 0         |
+----------------------------------------------+-----------+-----------+
| Transient Balance Involvement^15^            | 5         | 5         |
+----------------------------------------------+-----------+-----------+
| Tympanic Membrane Damage^16^                 | 6         | 5         |
+----------------------------------------------+-----------+-----------+

> ^1^ Investigator reported abnormal ear sensation consisting of
> fullness; event resolved during the normal healing period after
> implant.
>
> ^2^ Engineering analysis determined these events to be associated with
> the Printed Circuit Board (PCB) assembly operation. The operation has
> been modified and validated. Low levels of EMI have been found to be
> dependent upon the location and strength of the electromagnetic
> source.
>
> Three events reported as unresolved were due to their intermittent
> nature and are being monitored by the Investigator at the subjects'
> next visits.
>
> ^3^ Investigator reported middle ear effusion; event resolved during
> the normal healing period after implant.
>
> ^4^ Engineering analysis of the ECAs resulted in improved
> manufacturing processes and controls that have been implemented to
> eliminate systematic failures.
>
> ^5^ These events were related to the operative procedure or to the ECA
> fitting. In most of the cases these events resolved through longer
> healing periods post-implant or through ECA modifications. The
> Investigator is continuing to monitor the 2 subjects whose events were
> reported as unresolved.
>
> ^6^ Audiological data indicated that the hearing loss appears to be
> conductive. Investigator reported that he will continue to monitor the
> subject.
>
> ^7^ Each of the reported hematomas resolved through normal healing.
>
> ^8^ The infections also included Otitis Media (2) and Otitis Externa
> (2). Each of the reported events resolved through otologic management.
>
> ^9^ Outer ear irritation consisted of ear irritation (7), ear canal
> abrasion (2), ear edema (2), ear inflammation (2), and ear abrasion
> external (1).
>
> ^10^ The investigator reported this event as a transient neurological
> effect.
>
> ^11^ Processor failures were determined to be associated with the PCB
> assembly operation. The operation has been modified and validated.
> Analysis of the unresolved processor failure was in-process at the
> submission of this data.
>
> ^12^ Several observations of skin irritation were reported, including
> Eczema (2) and Pruritis (1). The investigators noted that each event
> was resolved.
>
> ^13^ Taste perversion can be related to the severing or irritation of
> the chorda tympani nerve during the implantation procedure. Resolution
> occurred spontaneously without treatment or surgical intervention. One
> case remains unresolved and will be monitored by the Investigator.
>
> ^14^ Subject medical records noted a past history of tinnitus. This
> case will be monitored by the Investigator.
>
> ^15^ Transient balance involvement comprised of reports of dizziness
> (1), nausea (1), vertigo (2), and vomiting (1). Each event resolved
> spontaneously.
>
> ^16^ Four reported events were resolved through surgical intervention
> and one event resolved without intervention. One event is not resolved
> and the Investigator is monitoring the subject.

#  (Non-serious adverse events unrelated to the device are not included in Table 1. These events consisted of: Unconfirmed ECA/Sound Processor failures (16), broken ECAs due to user abuse, improper use, or adjustments that damaged the device (7), tooth disorder (1), and infection in the non-implant ear (1)).

2.  Implant Device Failures and Replacements

> There were no implant device failures, revisions or replacements
> reported in this study. Some failures of the external Sound Processor
> and Earmold Coil Assembly were noted and analyzed. Improved
> manufacturing processes and controls have been implemented to
> eliminate systematic failures.

3.  Study Discontinuation

> There have been no study discontinuations. No subjects have asked for
> their implants to be removed.

###  Effectiveness  {#effectiveness .Head-4}

> The primary evaluation of efficacy is measured by comparing the
> difference in the amount of functional gain provided by the subject's
> optimally fit hearing aid to the SOUNDTEC Direct System. In addition
> efficacy shall be determined by the improved perceived benefit and
> satisfaction of the Direct System compared to the subject's optimally
> fit hearing aid.

A.  Increased Functional Gain

> The SOUNDTEC^®^ Direct System provided 7.9 dB additional functional
> gain when comparing the subject's acoustic hearing aid performance to
> that of the SOUNDTEC^®^ Direct System at the 20 week assessment. The
> DDHS demonstrated a statistically significant improvement in averaged
> aided sound field thresholds and functional gain from 500 -- 4000 Hz.
>
> At 36 and 52 weeks, the additional functional gain was 7.9 dB and 7.0
> dB, respectively.
>
> All three (3) time points, showed a statistically significant gain in
> average functional gain (each p-value \< 0.05, Paired t-test).
>
> Refer to Figure 3.
>
> **Figure 3**
>
> ![](media/image3.wmf)Additional functional gain is needed to
> compensate for the residual hearing threshold change. Aided thresholds
> are improved with the Direct System regardless of the decrease in
> residual hearing. Individual results will vary.
>
> Figure 4 shows aided thresholds comparing the Direct System to the
> acoustic hearing aid.
>
> **Figure 4**
>
> ![](media/image4.wmf)\
> 25% Avg. Improvement for 500-4000 Hz
>
> A similar analysis was performed for the high frequency average of
> 2000, 3000 and 4000 Hz (referred to in the protocol as the High
> Frequency Warble Tone Average-HFWTA of functional gain). The average
> improvement in the high frequency range at 20 weeks compared to
> performance with an acoustic hearing aid is 9.6 dB.
>
> At 36 and 52 weeks, the average improvement in HFWTA is 9.2 dB and
> 10.8 dB, respectively.
>
> At each of the three (3) time points, the improvement from performance
> with an acoustic hearing aid achieved statistical significance (each
> p-value \< 0.05, Paired t-test).

B.  Change in Articulation Index

> A secondary outcome measuring audibility is the Articulation Index
> (AI) and was assessed at pre-implant and 20 weeks. The AI was used to
> calculate the level of audibility based on aided hearing thresholds.
> The average improvement in Articulation Index scores comparing
> performance with the Direct System to the acoustic hearing aid was
> 11.9%. The improvement was statistically significant (p-value \< 0.05,
> Paired t-test).

C.  Speech Perception Results

> There are two (2) additional secondary efficacy measures of
> performance using audiometric speech tests. These consist of the NU-6
> (50-item word list) and the Speech Perception In Noise (SPIN) test.
> Tables 2 and 3 show the results on the aided NU-6 test and the SPIN
> (aided, low predictability sentences-raw scores) test. The results
> indicate average improvements with the DDHS on the NU-6 performance of
> 5.3%, 5.0%, and 12.2% across the 20, 36, and 52-week assessments,
> respectively. The NU-6 improvement from the acoustic hearing aid to
> the Direct System was statistically significant at the 20 and 52-week
> follow-ups. On average, SPIN scores were similar pre-implant and
> post-implant at the 20 and 36 week assessments.

  ---------------------------- ----------------------- -------------------
  **Table 2 - Summary of NU-6                          
  Aided Word Test (mean±SD)**                          

                               NU-6\                   Paired t-test\
                               (% Correct)             p-value

  **Baseline** (N=103)\        76.8±16.6               N/A
  Optimally Fit Hearing Aid                            

  20 Weeks (N=95)\             82.1±11.9               N/A
  Direct System                                        

  Improvement                  5.3±16.6                0.0026 \*

                                                       

  **36 Weeks** (N=33)\         83.8±10.3               N/A
  Direct System                                        

  Improvement                  5.0±15.4                0.0700 \*\*

                                                       

  **52 Weeks** (N=12)\         86.7±9.9                N/A
  Direct System                                        

  Improvement                  12.2±12.6               0.0066 \*

  \* Statistically Significant                         
  (Paired t-test, p-value \<                           
  0.05)                                                

  \*\* Borderline                                      
  Statistically Significant                            
  (Paired t-test. 0.05 \<                              
  p-value \< 0.10)                                     

  Reference: Clinical Report                           
  Appendices B.23-B.24                                 
  ---------------------------- ----------------------- -------------------

> The average change in SPIN aided, low predictability sentences at 20
> weeks was --0.1 words. For the 36 and 52-week follow-ups, the average
> improvements were 0.1 words and 4.2 words. The SPIN improvement from
> baseline to the 52-week follow-up was statistically significant
> (p-value = 0.0135, Paired t-test).

  ---------------------------- ---------------------- -------------------
  **Table 3 - Summary of SPIN                         
  Aided, Low Predictability                           
  Test (mean±SD)**                                    

                               **SPIN Aided, Low      **Paired t-test\
                               Predictability\        p-value**
                               (# Correct out of      
                               25)**                  

  **Baseline** (N=102)\        9.8±5.4                N/A
  Optimally Fit Hearing Aid                           

                                                      

  **20 Weeks** (N=95)\         10.0±5.0               N/A
  SOUNDTEC Direct                                    

  Improvement                  -0.1±5.9               0.8743

                                                      

  **36 Weeks** (N=22)\         9.9±5.9                N/A
  SOUNDTEC Direct                                    

  Improvement                  0.1±8.2                0.9664

                                                      

  **52 Weeks** (N=12)\         12.2±6.2               N/A
  SOUNDTEC Direct                                    

  Improvement                  4.2±5.0                0.0135 \*

  \* Statistically Significant                        

  Reference: Clinical Report                          
  Appendices B.25-B.26                                
  ---------------------------- ---------------------- -------------------

D.  Improvements in Perceived Benefit in Various Listening Situations

> The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a
> questionnaire used to assess the subject's perceived performance
> benefit in three areas: Ease of Communication (EC), Reverberation
> (RV), and Background Noise (BN). These were reported at pre-implant
> using the subject's acoustic hearing aid and at 20 weeks using the
> SOUNDTEC^®^ Direct System. On average, the hearing aid condition
> provided a score of 34.7 points of aided benefit and the Direct System
> 20 week condition provided a score of 42.2 points of aided benefit for
> the three subscales. While individual results varied, the average
> improvement across the three subscales is 7.2 ±19.9 points of
> improvement of aided benefit, which is statistically significant.
>
> Figure 5 shows the comparison between acoustic hearing aids and the
> Direct System for each of the three areas.
>
> ![](media/image5.wmf)

E.  Reduction in Feedback, Occlusion, and Distortion

> A second questionnaire, the Hough Ear Institute Profile (HEIP), was
> used to examine the following areas: satisfaction, acoustic feedback,
> perception of speech quality, occlusion, and tinnitus. The 20 Week
> HEIP results with the SOUNDTEC^®^ Direct System were compared to the
> subject's acoustic hearing aid values in 94 subjects (one subject of
> 95 completed all testing except the HEIP due to an error in test
> administration). All of these results were found to be statistically
> significant.

-   Out of 94 subjects responding, 84 of those subjects (89%) preferred
    the DDHS in terms of overall satisfaction. Satisfaction was measured
    by a four point scale with four being very satisfied and one being
    not at all satisfied. Using this scoring method, satisfaction with
    the Direct System increased by an average of 30.8% (median = 16.7%)
    from the subject's acoustic hearing aid (p-value \< 0.0001, Paired
    t-test).

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-   Sixty-three of 94 subjects (67%) reported having feedback with their
    acoustic hearing aid. At 20 weeks, only 8 (9%) subjects reported
    feedback using the SOUNDTEC^®^ Direct System (p-value \< 0.0001,
    McNemar's Test).

-   Out of 94 subjects responding, 93 subjects (99%) preferred the
    Direct System as having the least amount of feedback.

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-   Subject Perceived Quality of Speech was rated on a 7-point scale.
    The mean percentage increase relative to the subject's optimally fit
    hearing aid equaled 27.8% (median = 19.2%) for the SOUNDTEC^®^
    Direct System (p-value\< 0.0001, Paired t-test).

-   Out of 94 subjects responding, 84 of those subjects (89%) responded
    that they preferred the Direct System over their acoustic hearing
    aids in the area of sound quality.

-   Fifty of 92 subjects (54%) reported occlusion with their acoustic
    hearing aids. 21 of 92 subjects (23%) reported occlusion using the
    SOUNDTEC^®^ Direct System (p-value \< 0.0001, McNemar's Test). (Two
    of 94 subjects did not respond to the question concerning
    occlusion).

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-   Twenty-one of 41 (51%) subjects reporting tinnitus pre-implant
    reported that their hearing aid decreased their perception of
    tinnitus.

-   Twenty of 30 (67%) subjects reporting tinnitus post-implant reported
    that the Direct System decreased their perception of tinnitus.

###  Gender Analysis {#gender-analysis .Head-4}

> There were 68 males and 35 females that participated in the clinical
> study, accounting for 66% and 34% respectively. The higher proportion
> of male patients in the study is consistent with the higher incidence
> of male sensorineural hearing loss in the United States.

> Although the potential exists for minor differences in physiological
> response by gender for the target population, the minimal number of
> clinically significant findings does not indicate that gender
> differences are of clinical importance for this device.

###  Conclusions of Clinical Study {#conclusions-of-clinical-study .Head-3}

> The results from this study demonstrate reasonable assurance of
> evidence of safety and effectiveness. There are no serious safety
> concerns with the SOUNDTEC^®^ Direct System. A majority of the adverse
> events reported were expected, transient, and occurred at low
> incidence rates. There were no implant device replacements or surgical
> revisions necessary.
>
> The effectiveness of the SOUNDTEC^®^ Direct System is as follows:
> functional gain, speech measures, and subjective evaluations reached
> statistically significant improvements when comparing preoperative
> results with an optimally fit acoustic hearing aid to a 20 week
> assessment with the SOUNDTEC Direct System.

######## [Conclusion Drawn from the Studies]{.underline} {#conclusion-drawn-from-the-studies .Head-2}

The results of the preclinical and clinical studies provide reasonable
assurance of the safety and effectiveness of the SOUNDTEC Direct System
for the patient population, sensorineural hearing loss characteristics,
and specified indications for use.

######## [Panel Recommmendation]{.underline} {#panel-recommmendation .Head-2}

In accordance with the provisions of section 515(c)(2) of the act as
amended by the Safe Medical Devices Act of 1990, this PMA was not
referred to the Ear, Nose and Throat Devices Panel, an FDA advisory
committee, for review and recommendation because the information in the
PMA substantially duplicates information previously reviewed by this
panel.

######## [CDRH Decision]{.underline} {#cdrh-decision .Head-2}

Labeling provided includes two patient brochures. One is intended to
provide Information to the patient to assist in making the decision
whether to have the device implanted and the second is to assist the
patient in the use of the device after implantation.

The manufacturing facility was inspected on May 17, 2001 and found to be
in compliance with device Quality Systems Regulations.

FDA issued an approval order on September 7, 2001

######## XIII. [Approval Specifications]{.underline} {#xiii.-approval-specifications .Head-2 .unnumbered}

########  Directions for use: See the labeling. {#directions-for-use-see-the-labeling. .Head-2}

######## Warnings, hazards to health from use of device: See Indications, Contraindications, Warnings, and Precautions in the labeling. {#warnings-hazards-to-health-from-use-of-device-see-indications-contraindications-warnings-and-precautions-in-the-labeling. .Head-2}

-   Post approval requirements and restrictions: See Approval Order.