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The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.

The above mentioned TRT devices are digital noise generators and hearing aids which were developed to be used in a tinnitus retraining therapy. These products have up to four different programs, which can be programmed in shape and level to fit the individual users needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC, IS+ housing) or in a standard behind-the-ear instrument housing (S, S+, M and X housing).

This 510(k) Premarket Notification is for a set of Tinnitus Retraining Therapy (TRT) devices (various models under audifon arriva, elia, prado, and vico brands). The submission claims substantial equivalence to a predicate device, the audifon switch 8 TRT (K091552).

The core of the study is a comparison of technical specifications and performance against a predicate device, as opposed to a clinical trial with acceptance criteria for a new device's performance. The acceptance criteria are implicit in demonstrating that the new devices are "as safe, as effective, and perform as well as the predicate device."

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This study does not define explicit performance acceptance criteria in terms of sensitivity, specificity, accuracy, or similar metrics for diagnostic devices. Instead, the acceptance criteria are based on demonstrating equivalence in technical specifications and functionality to the predicate device. The "reported device performance" section will therefore compare the key characteristics of the new devices to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The submission relies on non-clinical performance data measured according to official standards (ANSI S3.22-2009) to demonstrate equivalence. This is not a test set of patient data. The data provenance is from the device manufacturer, and it is a retrospective comparison against published standards and the predicate device's specifications. No specific "sample size" in terms of patients or independent measurements is provided, other than the implication of standard compliance testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission relies on non-clinical performance data measured against engineering standards (ANSI S3.22-2009) and direct comparison of specifications to a predicate device, rather than expert-established ground truth from clinical data.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the context of clinical data requiring adjudication. The assessment is based on technical specifications and compliance with recognized standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC comparative effectiveness study was not done. The submission is based on technical and functional equivalence to a predicate device, not on clinical effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the devices are "algorithm only" in the sense that they are hardware that generates sounds, the evaluation itself is not about an "algorithm's diagnostic performance." Instead, it's a standalone technical evaluation of the device's acoustic characteristics and features against industry standards and a predicate device.

7. The Type of Ground Truth Used

The "ground truth" used is defined by:

• Official standards: Specifically, ANSI S3.22-2009 for the proper functioning of hearing aids.
• Predicate device specifications: The audifon switch 8 TRT (K091552) serves as the benchmark for comparison of features and performance characteristics.
• Regulatory requirements: Compliance with "special controls" as defined in 21 CFR 874.3400 for tinnitus maskers and OSHA noise exposure guidelines (29CFR 1910.95) for maximum output levels.

8. The Sample Size for the Training Set

Not applicable. These are not AI/ML devices that require a training set in the conventional sense. The "development" of these devices would involve engineering design and testing, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML model for this type of device submission.

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The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.

The audifon sueno devices are digital noise generators which were developed to be used in a tinnitus retraining therapy. These products have one program, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifit software. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC housing) or in a standard behind-the-ear instrument housing (S housing). The audifon sueno T devices (sueno T S and sueno T CIC) can be additional adjusted with three trimmer potentiometers by the hearing healthcare professional.

The provided document does not describe a study that establishes acceptance criteria for the audifon sueno devices, nor does it provide performance data from such a study. Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (audifon switch TRT, K091552).

Therefore, I cannot fill in the requested table and answer many of the questions directly. However, I can extract information related to the comparison with the predicate device, which serves as the basis for deeming the new device safe and effective.

Here's a summary based on the provided text:

Basis for Acceptance: The audifon sueno devices were accepted based on their substantial equivalence to the predicate device, audifon switch TRT (K091552). This means the FDA determined that the new devices are as safe and effective as the predicate device, and perform as well. This determination relies on comparing design, materials, intended use, targeted population, and non-clinical performance data (acoustic characteristics).

Key Information from the Document:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the substantial equivalence comparison):

It's important to note that the "acceptance criteria" here are not a set of predefined performance thresholds for a clinical study. Instead, they are the characteristics and performance aspects compared to the predicate device for demonstrating substantial equivalence. The "reported device performance" refers to the characteristics of the new device that align with or are justified against the predicate.

Regarding the Study Details:

The provided text describes a non-clinical performance data study to verify that the sueno devices have similar effectiveness to the predicate device, specifically measuring according to ANSI S3.22-2009. This is a standalone (algorithm only without human-in-the-loop performance) type of evaluation focusing on technical specifications rather than user interaction or clinical outcomes.

• 2. Sample size used for the test set and the data provenance: Not applicable. This was a non-clinical, technical performance test of the device's acoustic characteristics according to a standard, not a clinical study with a test set of human subjects or data. The data provenance would be from laboratory measurements in Germany (where audifon GmbH & Co. KG is located).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical dataset is not relevant to this type of non-clinical, technical performance testing.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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: No MRMC study was done. The device is a tinnitus masker, not an AI diagnostic tool for "human readers."
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, a standalone (non-clinical, technical performance) evaluation was done to measure acoustic characteristics according to ANSI S3.22-2009.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical performance test, the "ground truth" would be the specifications and requirements defined by the ANSI S3.22-2009 standard for hearing aids. The device's measured acoustic characteristics were compared against these standards and the known characteristics of the predicate device.
• 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
• 9. How the ground truth for the training set was established: Not applicable.

In summary: The acceptance of the audifon sueno devices was based on a demonstration of substantial equivalence to an existing predicate device (audifon switch TRT) through non-clinical performance testing (acoustic characteristics measurement according to ANSI S3.22-2009) and comparison of their intended use, design, and materials. No clinical studies involving human subjects or AI performance evaluations against expert-established ground truth were performed or referenced in this 510(k) summary.

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Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.

The target populations for the devices are as follows:

AN-Evo1 adults and children (≥ 12 years)
contact star evo1 adults and children (≥ 12 years)
contact mini adults and children (≥ 8 months)
apollon adults and children (≥ 12 years)

The apollon is a device where it is capable of utilizing either air or bone conduction.

AN-Evo1: Different to the more common air conduction hearing devices, with digital bone conducted hearing aids AN-Evo1 the sound is produced in a small vibrator and transmitted by direct contact to the mastoid. From here the sound is transmitted via the skull to the inner ear and transformed directly into nerve impulses. The AN-Evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aidfronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The AN-Evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The AN-Evo1 includes a digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O, OFF, T. Telecoil (induction coil) and M. Microphone. A Volume Control wheel is used to adjust the output power of the device. The AN-Evo1 is programmable via the HIPRO-Programming Box and BHMFit2 Fittingsoftware. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.

contact star evo1: Different to traditional air conduction hearing devices, by using bone conduction hearing aids contact star-evo1 the sound is produced in a broadband miniature vibration receiver and transmitted by direct skin contact to the mastoid, the area of the temple bone behind the ear. From here it is transmitted through the skull to the inner ear, where it is transformed into nerve impulses. The contact star evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aid-fronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The contact star evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The contact star evo1 includes a high performance digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O..OFF, T.Telecoil (induction coil) and M..Microphone. A Volume Control wheel is used to adjust the output power of the device. The contact star evo1 is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.

contact mini: The contact mini is a digital bone conduction hearing aid. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear. Contact mini consists of two interconnected units. An amplifier module and an bone vibrator. The amplifier module and the bone vibrator are connected through a wire cable. The amplifier module amplifies the sound and the bone vibrator converts them into vibrations. The bone vibrator has direct contact with the skin. The amplified sound moves through the bones of the inner ear, where it is directly converted into a neural stimulus. The contact mini is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different wearing such as headband, circlets and baseball caps. The contact mini is also available in different colors (black, blue and red). It can be used monaural or binaural. For monaural, the hearing aid use one active device and one bone vibrator. For binaural, the hearing aid uses two active devices and two bone vibrators. The contact mini includes a high performance digital programmable amplifier. The amplifier module is completely self-contained and has also a built in microphone for picking up sound. A Volume Control trimmer is used to adjust the output power of the device. The contact mini is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.

apollon: The apollon is also a bone conduction hearing aid. Unlike conventional hearing aids which depend upon acoustic coupling through air, the apollon is based on bone conduction technology. Sound is transmitted directly through the bones of the cochlea, bypassing the outer and middle ear. The apollon consists of a bone vibrator unit, a shirt pocket sized amplifier module and a wire cable for connecting the bone vibrator with the amplifier module. The bone vibrator is a convenient sized unit that is held against the head and is driven electrically to transmit the amplified sound as vibrations to the underneath bones of the skull. The amplifier module connects the bone vibrator through the wire cable and usually would be carried in the users pocket. The amplifier module is completely self-contained and is battery powered. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. As an added feature an auxiliary 3.5mm input jack allows the user to connect the apollon directly to TV, MP3 players, portable radios or even telephones without any additional adaptors. For selecting the operating mode, a four position mode switch is used. The positions are O..OFF, T..telecoil (induction coil), MT..microphone & telecoil (induction coil) and M..microphone. A Volume Control is used to adjust the output power of the device. Also, the possibility of a connection between via the DAI (Direct Audio Input) is available. A red LED (Light Emitting Diode) is used for optical low battery warning. The apollon is equipped with an high performance digital programmable amplifier system which can be adjusted via the BHMFit2 Programming software. The fitting will only be conducted by an audiologist, an hearing aid specialist or ENT.

The provided text describes a 510(k) premarket notification for several bone conduction hearing aids (AN-Evo1, contact star evo1, contact mini, apollon) seeking substantial equivalence to predicate devices (Viennatone AN - Fidelity F228 and Viennatone AS - Fidelity F229). The submission focuses on comparing the technical specifications and intended use of the new devices to the predicate devices.

However, the document does not contain any information about acceptance criteria, specific studies conducted to prove device performance against acceptance criteria, sample sizes used for test sets or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone algorithm performance studies.

The tables provided are "Comparison Tables" to demonstrate substantial equivalence to predicate devices, not performance against defined acceptance criteria from a study.

Therefore, most of the requested information cannot be extracted from the given text.

Here's an attempt to fill in what can be inferred from the provided context, noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

As specific acceptance criteria (e.g., minimum audiological performance thresholds for the new devices) and dedicated study results proving performance against these criteria are not explicitly stated in this 510(k) summary, this table cannot be fulfilled in the requested format. Instead, the document provides comparison tables against predicate devices to demonstrate substantial equivalence, focusing on technical specifications. The implication is that if the new device's specifications are comparable or superior and do not raise new safety or effectiveness concerns, it meets an implied "acceptance criterion" of being substantially equivalent to a legally marketed device.

Here's a summary of the comparisons provided for the new devices against their predicates. It's crucial to understand these are comparisons for substantial equivalence, not results from a performance study against predefined acceptance criteria.

Study that proves the device meets acceptance criteria:

The provided document describes a 510(k) premarket notification, which is a submission to the FDA demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparisons of technological characteristics, intended use, and performance data (if available and relevant to substantial equivalence), rather than a de novo clinical trial proving performance against specific acceptance criteria.

The "study" in this context is the comparison of the new devices (AN-Evo1, contact star evo1, contact mini, apollon) to their respective predicate devices (K935701 Starkey Laboratories Inc. VIENNATONE AN, VIENNATONE AS FIDELITY F228, FIDELITY F229). The conclusion reached by the FDA in their letter (page 12-13) is that the device is "substantially equivalent" to the predicate devices. The differences highlighted (e.g., digital circuitry, programmable features, battery life, different power sources) are deemed not to affect the safety and effectiveness of the device when used as labeled.

Missing Information:

The following requested details are not present in the provided document:

• 2. Sample sized used for the test set and the data provenance: No performance test set is explicitly mentioned or described as part of this 510(k) submission. The data provided are technical specifications.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth creation for a test set is described.
• 4. Adjudication method for the test set: Not applicable.
• 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. These are hearing aids, not AI interpretation devices.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no ground truth for a performance study is described. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices.
• 8. The sample size for the training set: Not applicable, as no training set for an algorithm is described.
• 9. How the ground truth for the training set was established: Not applicable.

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The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Timitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.

The jump C TRT is an analog noise generator that was developed to be used in a tinnitus retraining therapy. This product has a variable output level and an adjustable low-cut filter for a custom-tailored noise shape, which fits the individual user. It is housed in a standard housing for cymba application.

The provided text describes a 510(k) premarket notification for the Audifon jump C TRT tinnitus masker and related models. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove device effectiveness or meeting specific performance acceptance criteria through studies.

Therefore, much of the requested information about acceptance criteria, clinical study details, and performance metrics is not available in the provided document. The document primarily focuses on comparing the new device's features and intended use to a predicate device.

Here's what can be extracted and what is not available based on the input:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable. No clinical test set data is provided.
• Data Provenance: Not applicable. The submission relies on comparison to a predicate device and engineering specifications, not clinical data from a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No clinical test set or ground truth establishment by experts is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set or adjudication method is described.

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 device is a physical tinnitus masker, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is an analog noise generator, not an algorithm. Its operation is standalone in the sense that it generates noise independently, but it is intended for human use as part of a tinnitus management program.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. The submission is a 510(k) based on substantial equivalence, which primarily relies on comparing technical specifications and intended use to a predicate device. There is no mention of a ground truth in the context of clinical outcomes or expert consensus for efficacy. The "Quality Assurance" mentions "Measurements following ANSI 3.22-2003 to ensure proper functioning," which refers to technical performance standards rather than clinical ground truth.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable. No training set or ground truth for it is mentioned.

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