Predicate Devices

Interacoustic Diagnostic Audiometer AD229b, GSI 61 Clinical Audiometer

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard audiometry functions and compliance with relevant IEC/ISO standards, with no mention of AI or ML. The "automatic pure tone audiometry" feature is a common function in modern audiometers and does not inherently imply AI/ML.

Therapeutic

No
The device is used to diagnose hearing loss, not to treat it.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the audiometers are "used to determine hearing thresholds and assist to diagnose hearing loss." Additionally, some models are explicitly called "Diagnostic Audiometers" in the "Device Description."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the audiometers are "electroacoustic devices" and mentions outputs for various hardware components like headphones, bone conductors, and free-field systems. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The Entomed SA 201/202/203/204 series of audiometers are electroacoustic devices that produce sounds to test a person's hearing. They measure the response of the auditory system, not analyze biological samples.
Intended Use: The intended use is to determine hearing thresholds and assist in diagnosing hearing loss by presenting sounds and observing the patient's behavioral response. This is a functional test, not a diagnostic test performed on a biological sample.

Therefore, the device falls under the category of a diagnostic medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss.

Product codes (comma separated list FDA assigned to the subject device)

EWO

Device Description

The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals. The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers. The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry. The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required. All models can be used for determination of hearing thresholds and assist to diagnose hearing loss. All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The audiometer can be used on the majority of adults and children (from 4 years of age and upwards).

Intended User / Care Setting

All models should be operated by people with education/training within the field of audiometry such as Audiologists. Hearing Aid dispensers, Health Care and School nurses with appropriate training in audiology and Ear Nose Throat specialists.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Interacoustic Diagnostic Audiometer AD229b and GSI 61 Clinical Audiometer

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.

Summary

0

OCT - 2 2009

/

1092111

Summary of 510(k) owners administrative data

COMPANY NAME AND ADDRESS:

CONTACT PERSON:

EMAIL:

1

TELEPHONE NUMBER:

FAX:

TRADE NAME OF DEVICE:

COMMON NAME:

CLASSIFICATION:

PREDICATE DEVICE:

DATE SUMMARY PREPARED:

Entomed AB Bariumgatan 29 213 64 Malmö Sweden

Charlotte Mattisson

charlotte.mattisson@entomed.se

46 (40) - 210090
46 (40) - 210092

Entomed SA201/202 Screening Audiometer and Entomed SA203/204 Diagnostic Audiometer

Audiometer

Class II Medical Device, Reg no 874.1050, Product Code EWO

Interacoustic Diagnostic Audiometer AD229b and GSI 61 Clinical Audiometer

July 10 2009

1

2 Entomed AB

Entomed is a Swedish specialist company within the ENT (Ear-Nose-Throat) sector, founded 1986, with home production of audiometers, and an extensive agency business for Welch Allyn and diagnostical instruments from Grason-Stadler (GSI), Maico, and Oriola.

Up to year 2007 Entomed products were sold and distributed by GSI under the brand name GSI 66, GSI 67 and GSI 68. Since 2008 the products are sold directly from Entomed through a worldwide distributor network, under the brand names SA201TM SA202TM, SA 203TM and SA204TM

The SA20X series audiometer presented in this 510(k) submission is a new modernized generation of the well reputed product line. The new generation is digital and RoHS compatible.

3 Description of the device

The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals.

The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers.

The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry.

The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required.

All models can be used for determination of hearing thresholds and assist to diagnose hearing loss.

All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).

All models should be operated by people with education/training within the field of audiometry such as Audiologists. Hearing Aid dispensers, Health Care and School nurses with appropriate training in audiology and Ear Nose Throat specialists.

2

The performance characteristics for the SA 201/202/203/204 are such that they meet or exceed the following standards:

Standard	Name	SA201	SA202	SA203	SA204
IEC 60645-1 (1992)	Audiometers Part1; Pure Tone Audiometers	x	x	x	x
IEC 60645-2(1993)	Audiometers Part 2; Equipment for Speech Audiometry	NA	NA	NA	x
ISO 389:1991	Calibration of Air Conduction Audiometers	x	x	x	x
ISO 389-2	Calibration of Insert Phones	x	x	x	x
ISO 389-3	Calibration of Bone Vibrators	NA	NA	x	x
ISO 389-4	Calibration of Narrow Band Masking Noise	NA	NA	x	x
ISO 389-7	Calibration of Free Field Audiometers	NA	NA	x	x
IEC 60601-1 2nd edition 1988	Medical Electrical Equipment Part1: General Requirements for Safety	x	x	x	x
IEC 60601-1-2 3rd edition 2007	Medical Electrical Equipment Part1-2: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility - Requirements and Tests	x	x	x	x
ISO 8253-1	Audiometric Test Methods Part1; Basic Pure Tone Air and Bone Conduction Threshold Audiometry	x	x	x	x
ISO 8253-2	Audiometric Test Methods Part 2; Sound Field Audiometry with Pure Tone and Narrow Band Test Signals	NA	NA	x	x
ISO 8253-3	Audiometric Test Methods Part 3 Speech Audiometry	NA	NA	NA	x

.

NA = Not Applicable

、

3

Indication for use. 4

The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss.

The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to understand the basic principles of the test method when explained by the operator.

5 Summary of Performance Comparison between SA 204 and Interacoustic AD 229b (predicate) and GSI 61 (predicate)

The predicates selected for the SE discussion in this 510(k) are the Interacoustic Diagnostic Audiometer AD229b and GSI 61 Clinical Audiometer. The technical features of the SA204 are very similar to the Interacoustic AD 229b. However, the technical design using two separate, identical channels differs between the SA204 and the Interacoustic AD 229. The SA204 has 2 identical channels. By adding another predicate to the SE discussion that also has 2 identical channels, the GSI 61, it is shown that the technical solution to use two identical channels is well known and accepted.

Similarities between the predicates are presented in Tables 1a-1d and differences between the predicates are presented in Tables 2a - 2d.

4

| Comparison

Parameter	SA204	Interacoustic AD229b	GSI 61
Intended use	"The Entomed SA
201/202/203/204 series of
audiometers are screening
(201/202) and diagnostic
(203/204) audiometers used
to determine hearing
thresholds and assist to
diagnose hearing loss
The audiometer can be used
on the majority of adults
and children (from 4 years
of age and upwards). The
test person has to be able to
understand the basic
principles of the test method
when explained by the
operator"	"The Interacoustic Model AD229
Diagnostic Audiometer is indicated
for use in conducting diagnostic
hearing evaluations and assisting
in the diagnosis of possible
otologic disorders.
Because of its master hearing aid
capability this device is also
indicated for simulating a hearing
aid during audiometric testing thus
it may help in the selection and
adjustment of a patient's hearing
aid". (statement obtained from
510(k) summary from 510(k)
application K982249)	Determine hearing thresholds and
assist to diagnose hearing loss. It
can also be used in the selection
and adjustment of a patient's
hearing aid.
Air
Conduction
Pure Tone -
Frequency
Range and
Format	Range:
125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz
Format:
Steady,
Pulsed (2.5 pulses/sec),
Frequency Modulation
(Warble: ± 5 % triangular
10 Hz at 8 kHz, 8 Hz at 6
kHz and 5 Hz at 125 Hz - 4
kHz)	Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz.
Format:
Steady,
Multiple Pulses (250-5000 msec.
on/off),
Frequency Modulation (Warble: ±
5 % , 5Hz true sine wave)	Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz).
Format:
Steady,
Pulsed (Tone pulsed 200 msec ON,
200 msec OFF),
Frequency Modulation (Tone
modulated ± 5 % of centre
frequency at a rate of 5 Hz)
Bone
Conduction -
Frequency
Range	250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000,
8000 Hz	250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz	250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz
Narrow Band
Noise Range	125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz	125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz	125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz)
Speech Noise
Range	125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz	125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz	125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz)
Synchronous
Masking	Locks the noise attenuator
to the tone attenuator	Locks channel 2 attenuator to
channel 1 attenuator	Locks the noise attenuator to the
tone attenuator
Speech
Channel L and
R	Microphone: Input for live
speech testing and
communications
IN1 and IN2: Inputs for
recorded speech material
from external stereo
CD/tape player	Microphone: Input for live speech
testing and communications
Channel 1 and Channel 2: Inputs
for 2 channels for prerecorded
material
Speech Noise: Narrow Band noise
or White noise	Microphone: Input for live speech
testing and communications
External A and External B:
Accepts recorded speech material
from external stereo tape cassette
or CD player
Speech Noise: White noise

Table 1a Similarities between SA204 and Interacoustic AD229b and GSI 61
-------------------------------------------------------------------------	--	--	--	--	--	--	--

.

1

:

·

5

| | Speech Noise: White noise
filtered to a low and middle
frequency band, simulating
the average spectrum of
conversational speech | | |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communicatio
n
Operator/Test
subject | Talk Forward, Talk back
and Monitor / Live Speech
monitor headset | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset |
| Transducers | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH50P,
EARTone 3A,
Single Insert Phone $(470 \Omega)$
Sennheiser HDA 200,
Radioear B71 bone vibrator |
| Tone
Presentation | Manual
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation |
| Patient signal | Test subject response switch
push button | Reed switch push button | Subject response hand switch |
| Store
Function: | Internal Memory for AC
L/R and BC L/R | Internal Memory for AC L/R and
BC L/R and full speech curve | No internal memory for either AC
L/R, BC L/R or speech curve |
| Test: Auto
Threshold | Patient controlled Hughson
Westlake procedure
according to ISO 8253-1 | Patient controlled Hughson
Westlake procedure according to
ISO 8253-1 or OSHA procedure
with automatic re-check (US
edition only) | No auto threshold function
available |
| Comparison
Parameter | SA203 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA
201/202/203/204 series of
audiometers are screening
(201/202) and diagnostic
(203/204) audiometers used
to determine hearing
thresholds and assist to
diagnose hearing loss
The audiometer can be used
on the majority of adults
and children (from 4 years
of age and upwards). The
test person has to be able to
understand the basic
principles of the test method
when explained by the
operator" | "The Interacoustic Model AD229
Diagnostic Audiometer is indicated
for use in conducting diagnostic
hearing evaluations and assisting
in the diagnosis of possible
otologic disorders.
Because of its master hearing aid
capability this device is also
indicated for simulating a hearing
aid during audiometric testing thus
it may help in the selection and
adjustment of a patient's hearing
aid". | Determine hearing thresholds and
assist to diagnose hearing loss. It
can also be used in the selection
and adjustment of a patient's
hearing aid. |
| Air
Conduction
Pure Tone -
Frequency
Range and
Format | Range:
125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz
Format:
Steady,
Pulsed (2.5 pulses/sec),
Frequency Modulation
(Warble: ± 5 % triangular
10 Hz at 8 kHz, 8 Hz at 6
kHz and 5 Hz at 125 Hz - 4
kHz) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz
Format:
Steady,
Multiple Pulses (250-5000 msec.
on/off ),
Frequency Modulation (Warble: ±
5 % , 5Hz true sine wave) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz).
Format:
Steady,
Pulsed (Tone pulsed 200 msec ON,
200 msec OFF),
Frequency Modulation (Tone
modulated ± 5 % of centre
frequency at a rate of 5 Hz) |
| Bone
Conduction -
Frequency
Range | 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000,
8000 Hz | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz |
| Narrow Band
Noise Range | 125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Speech Noise
Range | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Synchronous
Masking | Locks the noise attenuator
to the tone attenuator | Locks channel 2 attenuator to
channel 1 attenuator | Locks the noise attenuator to the
tone attenuator |
| Speech
Channel L and
R | Speech Channels L and R
are not available | Microphone: Input for live speech
testing and communications
Channel 1 and Channel 2: Inputs | Microphone: Input for live speech
testing and communications
External A and External B: |

.

・

6

:

.

·

Table 1b. Similarities between SA203 and Interacoustic AD 229b and GSI 61

. .

7

| | | material
Speech Noise: Narrow Band noise
or White noise | from external stereo tape cassette
or CD player
Speech Noise: White noise |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communicatio
n
Operator/Test
subject | Talk Forward | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset |
| Transducers | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH50P,
EARTone 3A,
Single Insert Phone (470 Ω )
Sennheiser HDA 200,
Radioear B71 bone vibrator |
| Tone
Presentation | Manual
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation |
| Patient signal | Test subject response switch
push button | Reed switch push button | Subject response hand switch |
| Store
Function: | Internal Memory for AC
L/R and BC L/R | Internal Memory for AC L/R and
BC L/R and full speech curve | No internal memory for either AC
L/R, BC L/R or speech curve |
| Test: Auto
Threshold | Patient controlled Hughson
Westlake procedure
according to ISO 8253-1 | Patient controlled Hughson
Westlake procedure according to
ISO 8253-1 or OSHA procedure
with automatic re-check (US
edition only) | No auto threshold function
available |
| Comparison
Parameter | SA202 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA
201/202/203/204 series of
audiometers are screening
(201/202) and diagnostic
(203/204) audiometers used
to determine hearing
thresholds and assist to
diagnose hearing loss
The audiometer can be used
on the majority of adults
and children (from 4 years
of age and upwards). The
test person has to be able to
understand the basic
principles of the test method
when explained by the
operator" | "The Interacoustic Model AD229
Diagnostic Audiometer is indicated
for use in conducting diagnostic
hearing evaluations and assisting
in the diagnosis of possible
otologic disorders.
Because of its master hearing aid
capability this device is also
indicated for simulating a hearing
aid during audiometric testing thus
it may help in the selection and
adjustment of a patient's hearing
aid". | Determine hearing thresholds and
assist to diagnose hearing loss. It
can also be used in the selection
and adjustment of a patient's
hearing aid. |
| Air
Conduction
Pure Tone -
Frequency
Range and
Format | Range:
125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz
Format:
Steady,
Pulsed (2.5 pulses/sec),
Frequency Modulation
(Warble: ± 5 % triangular
10 Hz at 8 kHz, 8 Hz at 6
kHz and 5 Hz at 125 Hz - 4
kHz) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz
Format:
Steady,
Multiple Pulses (250-5000 msec.
on/off ),
Frequency Modulation (Warble: ±
5 % , 5Hz true sine wave) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz).
Format:
Steady,
Pulsed (Tone pulsed 200 msec ON,
200 msec OFF),
Frequency Modulation (Tone
modulated ± 5 % of centre
frequency at a rate of 5 Hz) |
| Bone
Conduction -
Frequency
Range | Bone conduction not
available | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz |
| Narrow Band
Noise Range | Narrow Band Noise not
available | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Speech Noise
Range | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Synchronous
Masking | Synchronous Masking not
available | Locks channel 2 attenuator to
channel 1 attenuator | Locks the noise attenuator to the
tone attenuator |
| Speech
Channel L and
R | Speech Channel L and R not
available | Microphone: Input for live speech
testing and communications
Channel 1 and Channel 2: Inputs
for 2 channels for prerecorded | Microphone: Input for live speech
testing and communications
External A and External B:
Accepts recorded speech material |
| | | material
Speech Noise: Narrow Band noise
or White noise | from external stereo tape cassette
or CD player
Speech Noise: White noise |
| Communicatio
n
Operator/Test
subject | Talk Forward | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset |
| Transducers | TDH39,
EARTone 5A,
Sennheiser HDA 200 | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH50P,
EARTone 3A,
Single Insert Phone (470 Ω )
Sennheiser HDA 200,
Radioear B71 bone vibrator |
| Tone
Presentation | Manual
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation |
| Patient signal | Test subject response switch
push button | Reed switch push button | Subject response hand switch |
| Store
Function: | Internal Memory for AC
L/R | Internal Memory for AC L/R and
BC L/R and full speech curve | No internal memory for either AC
L/R, BC L/R or speech curve |
| Test: Auto
Threshold | Patient controlled Hughson
Westlake procedure
according to ISO 8253-1 | Patient controlled Hughson
Westlake procedure according to
ISO 8253-1 or OSHA procedure
with automatic re-check (US edition only) | No auto threshold function
available |
| Comparison
Parameter | SA201 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA
201/202/203/204 series of
audiometers are screening
(201/202) and diagnostic
(203/204) audiometers used
to determine hearing
thresholds and assist to
diagnose hearing loss
The audiometer can be used
on the majority of adults
and children (from 4 years
of age and upwards). The
test person has to be able to
understand the basic
principles of the test method
when explained by the
operator" | "The Interacoustic Model AD229
Diagnostic Audiometer is indicated
for use in conducting diagnostic
hearing evaluations and assisting
in the diagnosis of possible
otologic disorders.
Because of its master hearing aid
capability this device is also
indicated for simulating a hearing
aid during audiometric testing thus
it may help in the selection and
adjustment of a patient's hearing
aid". | Determine hearing thresholds and
assist to diagnose hearing loss. It
can also be used in the selection
and adjustment of a patient's
hearing aid. |
| Air
Conduction
Pure Tone -
Frequency
Range and
Format | Range:
125, 250, 500, 750, 1000,
1500, 2000, 3000, 4000,
6000, 8000 Hz
Format:
Steady,
Pulsed (2.5 pulses/sec),
Frequency Modulation
(Warble: ± 5 % triangular
10 Hz at 8 kHz, 8 Hz at 6
kHz and 5 Hz at 125 Hz - 4
kHz) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz
Format:
Steady,
Multiple Pulses (250-5000 msec.
on/off ),
Frequency Modulation (Warble: ±
5 % , 5Hz true sine wave) | Range:
125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz).
Format:
Steady,
Pulsed (Tone pulsed 200 msec ON,
200 msec OFF),
Frequency Modulation (Tone
modulated ± 5 % of centre
frequency at a rate of 5 Hz) |
| Bone
Conduction -
Frequency
Range | Bone conduction not
available | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,
3000, 4000, 6000, 8000 Hz |
| Narrow Band
Noise Range | Narrow Band Noise not
available | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Speech Noise
Range | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,
2000, 3000, 4000, 6000, 8000,
12000 Hz
(High frequency as "Optional
accessories" 8000 Hz to 20 000
Hz) |
| Synchronous
Masking | Synchronous Masking not
available | Locks channel 2 attenuator to
channel 1 attenuator | Locks the noise attenuator to the
tone attenuator |
| Speech
Channel L and
R | Speech Channel L and R not
available | Microphone: Input for live speech
testing and communications
Channel 1 and Channel 2: Inputs
for 2 channels for prerecorded | Microphone: Input for live speech
testing and communications
External A and External B:
Accepts recorded speech material |
| | | material
Speech Noise: Narrow Band noise
or White noise | from external stereo tape cassette
or CD player
Speech Noise: White noise |
| Communicatio
n
Operator/Test
subject | Talk Forward | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset | Talk Forward, Talk back and
Monitor / Live Speech monitor
headset |
| Transducers | TDH39,
EARTone 5A,
Sennheiser HDA 200 | TDH39,
EARTone 5A,
Sennheiser HDA 200,
Radioear B71 bone vibrator | TDH50P,
EARTone 3A,
Single Insert Phone (470 Ω )
Sennheiser HDA 200,
Radioear B71 bone vibrator |
| Tone
Presentation | Manual
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation | Manual or Reverse
Single Pulse
Multiple Pulses
Frequency Modulation |
| Patient signal | Test subject response switch
push button | Reed switch push button | Subject response hand switch |
| Store
Function: | Internal Memory for one
AC L/R audiogram | Internal Memory for AC L/R and
BC L/R and full speech curve | No internal memory for either
L/R, BC L/R or speech curve |
| Test: Auto
Threshold | Auto threshold not available | Patient controlled Hughson
Westlake procedure according to
ISO 8253-1 or OSHA procedure
with automatic re-check (US
edition only) | No auto threshold function
available |

: :

8

Table 1c. Similarities between SA202 and Interacoustic AD 229b and GSI 61

9

.

:

and the comments of the comments of the comments of the comments of

10

.

Table 1d. Similarities between SA201 and Interacoustic AD 229b and GSI 61

11

and the comments of the comments of the comments of the comments of

:

、

12

Table 2a Differences between SA204 and Interacoustic AD229b and GSI 61

Comparison Parameter	SA204	Interacoustic AD229b	GSI 61
Masking	White Noise and	White Noise available.	White Noise and Routing of
-White Noise	Routing of masking	Routing of masking not	Masking
-Routing of masking	not available	available	available
Frequency Selection	Any frequency can be	125, 250, 750, 1500 Hz	No frequency can be deselected
	deselected	or 8kHz can be
		deselected
Tone Presentation	Not Available	Available	Available
-Reverse Tone
Routing possibilities	No routing
possibilities	No routing possibilities	Routing possibilities available
High Frequency	Not Available	Not Available	Available at 9, 10, 11.2, 12.5, 14,
16, 18, 20 kHz
Digital Signal Generator	Yes	No	No
CF Card and Calibration Card	Yes	No	No
Display audiograms on Front	No	No	Yes
Display
Compatible Windows Software	AudiMax II	OtoAccess™ Database
and diagnostic modules
software
PrintView,
Interacoustics database
and diagnostic modules,
NOAH	Audi-Link Audiometer driver for
NOAH
Internal Memory for full	Not Available	Available	Available
speech curve
Tests	SISI, ALT, ABLB,	SISI, ALT and High	SISI, ALT and High Frequency are
-SISI	Stenger, Stenger	Frequency are not	available.
-ALT	Speech and High	available.	ABLB, Stenger and Stenger
-ABLB	Frequency are not	ABLB, Stenger and	Speech are not available.
-Stenger	available	Stenger Speech are
-Stenger Speech		available.
-High Frequency
2 identical channels	Yes	No	Yes
Dimensions (LxWxH)	37.6x26.4x7.3 cm	36x26x10 cm	50x39x32 cm
Weight	1.25 kg	1.8 kg	8.7 kg
Power Supply	External, 100-240 V	External, 100-115 V or
230 V	Internal Power Supply

Power Consumption	15 W	40 W	90 W
Attenuator Controls	1 HL rotary control
for test signal
intensity and 1 HL
rotary control for	1 HL rotary control for
channel 1 and 1 HL
rotary control for
channel 2	- 2 independent HL rotary controls
for test signal and masking
intensity
-push buttons that allows intensity

13

Comparison Parameter	SA203	Interacoustic AD229b	GSI 61
Masking	White Noise and	White Noise available.	White Noise and Routing of
-White Noise	Routing of masking	Routing of masking not	Masking
-Routing of masking	not available	available	available
Frequency Selection	Any frequency can be
deselected	125, 250, 750, 1500 Hz
or 8kHz can be
deselected	No frequency can be deselected
Tone Presentation	Not Available	Available	Available
-Reverse Tone
Routing possibilities	No routing
possibilities	No routing possibilities	Routing possibilities available
High Frequency	Not Available	Not Available	Available at 9, 10, 11.2, 12.5, 14,
16, 18, 20 kHz
Digital Signal Generator	Yes	No	No
CF Card and Calibration Card	Yes	No	No
Display audiograms on Front
Display	No	No	Yes
Compatible Windows Software	AudiMax II	OtoAccess™ Database
and diagnostic modules
software
PrintView,
Interacoustics database
and diagnostic modules,
NOAH	Audi-Link Audiometer driver for
NOAH
Internal Memory for full
speech curve	Not Available	Available	Available
Tests	SISI, ALT, ABLB,
Stenger, Stenger
Speech and High
Frequency are not
available	SISI, ALT and High
Frequency are not
available.
ABLB, Stenger and
Stenger Speech are
available.	SISI, ALT and High Frequency are
available.
ABLB, Stenger and Stenger
Speech are not available.
-SISI
-ALT
-ABLB
-Stenger
-Stenger Speech
-High Frequency
2 identical channels	Yes	No	Yes
Dimensions (LxWxH)	37.6x26.4x7.3 cm	36x26x10 cm	50x39x32 cm
Weight	1.15 kg	1.8 kg	8.7 kg
Power Supply	External, 100-240 V	External, 100-115 V or
230 V	Internal Power Supply
Power Consumption	15 W	40 W	90 W
Attenuator Controls	1 HL rotary control
for test signal
intensity and 1 HL
rotary control for
masking intensity	1 HL rotary control for
channel 1 and 1 HL
rotary control for
channel 2	- 2 independent HL rotary controls
for test signal and masking
intensity
-push buttons that allows intensity
step size of 1, 2 or 5 dB

,

·

Table 2b Differences between SA203 and Interacoustic AD229b and GSI 61

14

Comparison Parameter	SA202	Interacoustic AD229b	GSI 61
Masking	White Noise and	White Noise available.	White Noise and Routing of
-White Noise	Routing of masking	Routing of masking not	Masking
-Routing of masking	not available	available	available
Frequency Selection	Any frequency can be	125, 250, 750, 1500 Hz	No frequency can be deselected
	deselected	or 8kHz can be
		deselected
Tone Presentation	Not Available	Available	Available
-Reverse Tone
Routing possibilities	No routing
possibilities	No routing possibilities	Routing possibilities available
High Frequency	Not Available	Not Available	Available at 9, 10, 11.2, 12.5, 14,
			16, 18, 20 kHz
Digital Signal Generator	Yes	No	No
CF Card and Calibration Card	Yes	No	No
Display audiograms on Front	No	No	Yes
Display
Compatible Windows Software	AudiMax II	OtoAccessTM Database	Audi-Link Audiometer driver for
		and diagnostic modules	NOAH
		software
		PrintView,
		Interacoustics database
		and diagnostic modules,
		NOAH
Internal Memory for full	Not Available	Available	Available
speech curve
Tests	SISI, ALT, ABLB,	SISI, ALT and High	SISI, ALT and High Frequency are
-SISI	Stenger, Stenger	Frequency are not	available.
-ALT	Speech and High	available.	ABLB, Stenger and Stenger
-ABLB
-Stenger	Frequency are not	ABLB, Stenger and	Speech are not available.
-Stenger Speech	available	Stenger Speech are
-High Frequency		available.
2 identical channels	Yes	No	Yes
Dimensions (LxWxH)	37.6x26.4x7.3 cm	36x26x10 cm	50x39x32 cm
Weight	1.15 kg	1.8 kg	8.7 kg
Power Supply	External, 100-240 V	External, 100-115 V or	Internal Power Supply
		230 V
Power Consumption	15 W	40 W	90 W
Attenuator Controls	1 HL rotary control	1 HL rotary control for	- 2 independent HL rotary controls
	for test signal	channel 1 and 1 HL	for test signal and masking
	intensity and 1 HL	rotary control for	intensity
	rotary control for	channel 2	-push buttons that allows intensity
	masking intensity		step size of 1, 2 or 5 dB

.

:

Table 2c Differences between SA202 and Interacoustic AD229b and GSI 61

15

Comparison Parameter	SA201	Interacoustic AD229b	GSI 61
Masking	White Noise and	White Noise available.	White Noise and Routing of
-White Noise	Routing of masking	Routing of masking not	Masking
-Routing of masking	not available	available	available
Frequency Selection	Any frequency can be	125, 250, 750, 1500 Hz
or 8kHz can be	No frequency can be deselected
	deselected	deselected
Tone Presentation	Not Available	Available	Available
-Reverse Tone
Routing possibilities	No routing
possibilities	No routing possibilities	Routing possibilities available
High Frequency	Not Available	Not Available	Available at 9, 10, 11.2, 12.5, 14,
16, 18, 20 kHz
Digital Signal Generator	Yes	No	No
CF Card and Calibration Card	Yes	No	No
Display audiograms on Front
Display	No	No	Yes
Compatible Windows Software	AudiMax II	OtoAccess™ Database
and diagnostic modules
software
PrintView,
Interacoustics database
and diagnostic modules,
NOAH	Audi-Link Audiometer driver for
NOAH
Internal Memory for full
speech curve	Not Available	Available	Available
Tests	SISI, ALT, ABLB,
Stenger, Stenger
Speech and High
Frequency are not
available	SISI, ALT and High
Frequency are not
available.
ABLB, Stenger and
Stenger Speech are
available.	SISI, ALT and High Frequency are
available.
ABLB, Stenger and Stenger
Speech are not available.
-SISI
-ALT
-ABLB
-Stenger
-Stenger Speech
-High Frequency
2 identical channels	Yes	No	Yes
Dimensions (LxWxH)	37.6x26.4x7.3 cm	36x26x10 cm	50x39x32 cm
Weight	1.15 kg	1.8 kg	8.7 kg
Power Supply	External, 100-240 V	External, 100-115 V or
230 V	Internal Power Supply
Power Consumption	15 W	40 W	90 W
Attenuator Controls	1 HL rotary control
for test signal
intensity and I HL
rotary control for
masking intensity	1 HL rotary control for
channel 1 and 1 HL
rotary control for
channel 2	- 2 independent HL rotary controls
for test signal and masking
intensity
-push buttons that allows intensity
step size of 1, 2 or 5 dB

:

Table 2d Differences between SA201 and Interacoustic AD229b and GSI 61

;

16

Technical Design Differences between the SA204 and Predicates

6.1 Digital Signal Processor

6

The tone generator within the SA204 is a Digital Signal Processor. This might be different to the GSI 61 and the AD229b. Most audiometers operate by using an analog tone generator.

This may be a new way to produce a tone, at a certain frequency, within the field of audiometry. However the digital technique has been used within other competence areas for several years hence it is well-known and accepted (for example within computers, mp3-players, video-game consoles). Generating the frequency digitally is a modern way to produce a signal. The frequencies and SPL levels produced are such that they meet the demands of those described in the standard IEC 60645-1 and 60645-2.

6.2 CF Card and Calibration Card

The SA 201/202/203/204 uses a concept where part of the software necessary for operating the audiometer and calibrating the audiometer is stored on separate memory cards that can be attached and removed from the main board. These cards are here referred to as the Calibration CF Card and the CF Card. CF stands for Compact Flash. The CF Card contains the CPU and memory.

Traditionally EPROM has been used for control and storage of software version, set-up data, calibration data etc. Technically it is much more difficult to manipulate software on a CF Card than on an EPROM and hence the risks for unauthorized changes decreases when using the CF Cards.

Furthermore, by using one CF Card for calibration and another for operation of the audiometer, and restricting the access to the Calibration CF Card, the risk for calibration data being faulty/changed/altered is minimized.

17

Image /page/17/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Entomed AB c/o Charlotte Mattisson, Ph.D. Quality Assurance and Regulatory Affairs Bariumgatan 29 SE-213 64 Malmö Sweden

OCT - 2 2009

Re: K092111

Trade/Device Name: Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer

Regulation Number: 21 CFR 874.1050

Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: July 10, 2009 Received: July 14, 2009

Dear Dr. Mattisson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

18

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

19

K092111

Indication for Use

510(k) Number (if known):

Device Name:

Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer

Indication For Use:

The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss.

The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.

Prescription Use AND/OR Over-The Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Shullon hey
(Division Sign-Off)

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

510(k) Number

K092111

× Prescription Use (Per 21 CFR 801.109)