(133 days)
The Titan with DPOAE440 is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Titan with DPOAE440 includes all ages.
The Titan with ABRIS440 is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Titan with ABRIS440 is newborns.
The instrument is audiometric equipment used for testing middle ear, inner ear and brainstem abnormalities.
The Titan is a combination of:
- Audiometric device for measurement of aural acoustic impedance (IMP) (Cleared . under K083861)
- Audiometric device for measurement of otoacoustic emissions (OAE) .
- Audiometric device for measurement of auditory brainstem responses (ABR) ●
The Titan can have one of three functions depending on license:
The Titan IMP test is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear.
The Titan OAE test generates an acoustic stimulus in the ear canal at a moderate intensity level. The stimulus vibrates a thin membrane in the cochlear, and activates the outer hair cells located on the membrane. This activation is propagated back through the middle ear as sound into the ear canal. Microphone(s) detects OAE-related sounds.
The Titan ABR test produces a short acoustic stimulus and measures via cutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The test uses an automatic detection algorithm to determine if an ABR is evoked in response to the short acoustic stimulus. The output of the device is either PASS (ABR detected) or REFER (ABR is not detected).
The Titan with DPOAE440 is intended as clinical audiometer. The Titan with ABRIS440 is intended as a screener audiometer.
The Interacoustics Titan with ABRIS440 and Titan with DPOAE440 devices are audiometric equipment used for testing middle ear, inner ear, and brainstem abnormalities. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document evaluates the Titan with ABRIS440 against the Maico MB 11 (predicate device) and the Titan with DPOAE440 against the DPOAE20 (predicate device). The "Equivalence" column in the tables below serves as the acceptance criteria and indicates whether the new device met the criteria (Same, Similar).
Titan with ABRIS440 vs. Maico MB 11 (Predicate Device)
| Description | Maico, MB 11 (Predicate) | Titan with ABRIS 440 (New) | Equivalence |
|---|---|---|---|
| Indications for use | The Maico MB 11 with BERAphone and the MB 11 Standard are intended to generate evoked auditory brainstem response (ABR) -based measurements for newborn hearing screening, providing a PASS/REFER result. | The Titan with ABRIS440 is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. | Similar (Wording just a little different) |
| Target population | Newborns | Newborns | Same |
| Intended user | The User does not require special technical skills or interpretation of the results. | The User does not require special technical skills or interpretation of the results. | Same |
| Anatomical sites | Examination of Ear and hearing nerves | Examination of Ear and hearing nerves | Same |
| Safety standards | IEC 60601-1 | IEC 60601-1 | Same |
| Performance standard | IEC 60645-7 (Type 2) | IEC 60645-7 (Type 2) | Same |
| Device Type | Screening device (PASS/REFER) result | Screening device (PASS/REFER) result | Same |
| System Configuration | 1-channel ABR system operated through a base unit connected via a USB port to any standard computer (Laptop Computer recommended) | 1-channel ABR system operated through a handheld base unit. The base unit can be operated stand alone or PC controlled through USB or Bluetooth. | Similar (Titan can work as stand alone) |
| Display information | Testing sequence along with current EEG parameters (number of sweeps, number of artifacts, SNR, and artifact rejection system setting) | PASS/REFER status, indicated with value between 0 and 100% where 100% indicates a pass. EEG peak or RMS value, rejection status, residual noise and what transducer(s) are detected. | Similar (Minor differences in displayed information) |
| Electrode quality check | YES | YES | Same |
| Impedance Test (Quality control) | Indicator in three levels. Red: above 10kOhm Yellow: between 10 & 8kOhm Green: below 8kOhm | Before recording: Electrode impedance is measured if they are above 10kOhm, below 10 kOhm or below 3 kOhm. | Similar (Difference in mid-range due to measurement frequencies, Titan may require more careful electrode placement) |
| Binaural screening | YES | YES | Same |
| Pre-amplifier channels | 1 | 1 | Same |
| Stimulus | Chirps | Chirps | Same |
| Pre-amplifier Gain | 86 dB | 64 dB | Similar (Depends on amplifier characteristics, no influence on measuring results) |
| Filtering | HW HP 30Hz filters of 1st order | Two HW HP filters of 1st order: Cut-off frequencies 7Hz and 45Hz | Similar (Both look at frequencies above 80Hz; response identical at that frequency. Basic purpose is to eliminate DC components) |
| Masking | None | None | Same |
| Transducers | BERAphone TDH39 EAR 3A Insert phones | Titan Probe TDH39 EAR 3A Insert phones | Similar (Titan probe is dedicated for Titan as BERAphone for MB 11) |
| Stimulus rate | 92.5/s | 90/s | Similar |
| Screening level | 35dBHL | 35dBHL | Same |
| Screening measurement | 180 seconds | 180 seconds | Same |
Titan with DPOAE440 vs. DPOAE20 (Predicate Device)
| Description | DPOAE20 (Predicate) | DPOAE440 (New) | Equivalence |
|---|---|---|---|
| Indications for use | The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli. The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE probe which is placed in the ear canal. The OAE response from the ear is recorded and processed by the Eclipse and the DPOAE2O software and then displayed on the computer screen for evaluation. | The Titan with DPOAE440 is intended for use in the diagnostic audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. | Similar (Wording just a little different) |
| Target population | The patient group includes all ages | The patient group includes all ages | Same |
| Intended user | Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health- professionals concerned with measuring auditory functions. | The Titan is designed to be used only by skilled personnel such as audiologists, ENT surgeons, and doctors, hearing healthcare professionals or personnel with similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted. | Same |
| Evaluation method | DPOAE | DPOAE | Same |
| Safety standard | IEC 60601-1 | IEC 60601-1 | Same |
| EMC standard | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Performance standard | IEC 60645-6 (Type 2) | IEC 60645-6 (Type 2) | Same |
| Test signals | IEC 60645-1/ANSI S3.6, IEC 60645-3 | IEC 60645-1/ANSI S3.6, IEC 60645-3 | Same |
| Stimulus: Frequency Range | 500-8000 Hz | 500 to 10000 Hz | Similar (Extended range is a technical improvement due to better technology and probes) |
| Stimulus: Frequency Step | 50 Hz | 25 Hz | Similar (Better resolution possible due to better technology) |
| Stimulus: Level | 30-75 dB SPL (70 dB above 6kHz) | 30 to 80 dB SPL (75 dB SPL for 6kHz and 65 dB SPL for 8kHz and 10kHz) | Similar (Extended range is a technical improvement due to better technique and probes) |
| Stimulus: Level Step | 1 dB SPL | 1 dB SPL | Same |
| Transducer | Dedicated DPOAE20/TEOAE25 probe | Dedicated IOW Probe | Similar (New transducer due to hardware design, but same characteristics as predicate) |
| Probe detection | None | Auto detection | Different (Probe unit has built-in memory for calibration values) |
| Recording Analysis time | Minimum 2 sec to unlimited test time. | Minimum 2 seconds to unlimited time | Same |
| Recording A/D Resolution | 16 bit, 7.3 Hz resolution | 24 bit, 5.38 Hz resolution | Similar (Better resolution due to better technology) |
| Artifact Reject System | -30 -> +30 dB SPL or off. | -30 to +30 dB SPL or off | Same |
| Stimulus Tolerance | Adjustable between 1 and 10 dB | Adjustable between 1 and 10 dB | Same |
| SNR Criteria | Adjustable between 1 and 20 dB | Adjustable between 3 and 25 dB | Similar (Limits adjusted to better fit real-world practice, giving higher evidence for response) |
| Probe check window | 256 points frequency response of the ear canal due to a click stimulus presented with a rate of 100 Hz at 80 dB SPL | 1024 points frequency response of the ear canal due to a click stimulus | Similar (Better resolution due to better technology used) |
| DP-Response window | 4096 points frequency response | 4096 points frequency response | Same |
| Display General Display gain | Applicable during testing | Applicable during testing | Same |
| Display | Stimulus level and type | Stimulus level and type, Basic and advanced view | Similar (A simpler (basic) view has been introduced) |
| Database | Supported by Interacoustics OtoAccess™ database. Operating under NOAH is possible, using IA NOAHLink. | Supported by Interacoustics OtoAccess™ database. Operating under NOAH is possible, using IA NOAHLink. | Same |
2. Sample size used for the test set and the data provenance
The provided document states: "No clinical tests were performed". Instead, the device's substantial equivalence was determined based on its conformity to international standards and comparison to predicate devices, which implies that no specific test set of patient data was used for a clinical performance study as part of this submission. Therefore, data provenance is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical tests were performed and no ground truth was established by experts for a test set in this submission. The comparison relies on technical specifications and international standards.
4. Adjudication method for the test set
Not applicable, as no clinical tests were performed and no ground truth was established by experts for a test set in this submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The document does not describe an MRMC study or AI assistance. The device is a diagnostic tool, not an AI-powered diagnostic aide.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
For the Titan with ABRIS440, the device includes an "automatic detection algorithm to determine if an ABR is evoked in response to the short acoustic stimulus. The output of the device is either PASS (ABR detected) or REFER (ABR is not detected)." This indicates a standalone algorithmic performance component. However, no specific standalone performance study results, such as sensitivity or specificity, are presented in this submission. The study relies on comparison to predicate devices and adherence to standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the statement "No clinical tests were performed," there was no direct patient-level ground truth established for the purpose of this 510(k) submission. The ground truth for the equivalence claims is implicitly based on the established safety and performance characteristics of the predicate devices and adherence to relevant international standards (IEC 60601-1, IEC 60601-1-2, IEC 60645-7, IEC 60645-6).
8. The sample size for the training set
Not applicable, as no clinical tests were performed and the device is not described as utilizing a machine learning algorithm that would require a training set in the context of this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable, as no training set was used in the context of this 510(k) submission.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).