ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

Q: Who is the manufacturer of ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

Entomed AB filed the 510(k) submission for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204 (K092111).

Q: What is the FDA product code for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

EWO. It is classified under 21 CFR 874.1050 as a Class 2 device in the Ear, Nose, Throat panel.

Q: What is the regulatory pathway for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

Interacoustic Diagnostic Audiometer AD229b (K982249); GSI 61 Clinical Audiometer.

Q: Who can help prepare an FDA 510(k) submission like ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K092111 · Entomed AB · EWO · Oct 2, 2009 · Ear, Nose, Throat

Device Facts

Record ID	K092111
Device Name	ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204
Applicant	Entomed AB
Product Code	EWO · Ear, Nose, Throat
Decision Date	Oct 2, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1050
Device Class	Class 2
Attributes	Pediatric

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. 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.

Device Story

Electroacoustic audiometers (SA201/202 screening; SA203/204 diagnostic) generate controlled test tones and signals for hearing threshold determination. Inputs include manual operator controls and patient response switches; SA203/204 include synchronized masking. Digital signal processor generates frequencies; outputs delivered via headphones (TDH39, Sennheiser HDA200, EARtone 5A) or bone vibrators (B71). Used in clinical settings by audiologists, ENT specialists, or trained nurses. Device assists clinicians in diagnosing hearing loss by measuring patient response to stimuli. Modernized digital generation replaces traditional analog tone generation; calibration and operational software stored on removable Compact Flash (CF) cards to enhance security and prevent unauthorized calibration changes.

Clinical Evidence

Bench testing only. Performance verified against IEC 60645-1, IEC 60645-2, ISO 389 series, and ISO 8253 series standards for audiometric equipment and test methods.

Technological Characteristics

Digital signal processor-based tone generation; RoHS compatible. Dimensions: 37.6x26.4x7.3 cm; Weight: 1.15-1.25 kg. Power: External 100-240V. Connectivity: CF card slots for calibration/operation. Transducers: TDH39, Sennheiser HDA200, EARtone 5A, B71 bone vibrator. Standards: IEC 60645-1/2, ISO 389-1/2/3/4/7, ISO 8253-1/2/3, IEC 60601-1, IEC 60601-1-2.

Indications for Use

Indicated for determining hearing thresholds and diagnosing hearing loss in adults and children aged 4 years and older capable of understanding test principles.

Regulatory Classification

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.

Predicate Devices

Interacoustic Diagnostic Audiometer AD229b (K982249)
GSI 61 Clinical Audiometer

Submission Summary (Full Text)

{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 |…

ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

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Submission Summary (Full Text)

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ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA204

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

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