Search Results

The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.

ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded plug-in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible.

Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station.

The ALGO 7i offers hearing screening using AABR technology.

The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics. Besides that, result information is displayed as PASS/REFER/INCOMPLETE.

The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.

Here's a breakdown of the acceptance criteria and the study proving the ALGO 7i device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ALGO 7i are primarily established through its substantial equivalence to the predicate device, ALGO 3i, especially regarding its ABR (Auditory Brainstem Response) technology and performance metrics. The text describes the algorithmic sensitivity and typical specificity observed in studies of the predicate device, which is foundational to the ALGO 7i's acceptance.

Details of the Study Proving Device Meets Acceptance Criteria:

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: No new clinical performance data was collected for the ALGO 7i. The performance evaluation relies entirely on the established performance of its predicate device, ALGO 3i, and non-clinical bench testing.
   • Data Provenance (Predicate Device): The original ABR template was derived from the responses of 35 neonates to 35 dBnHL click stimuli. This data was collected at Massachusetts Eye and Ear Infirmary during the design and development of the original automated infant hearing screener (ALGO I device). Clinical studies supporting the predicate ALGO devices (e.g., ALGO 3i) are referenced in the literature review. The studies mentioned are:
     • Peters, J. G. "An automated infant screener using advanced evoked response technology." The Hearing Journal 39 (1986): 25-30.
     • Herrmann, Barbara S., Aaron R. Thornton, and Janet M. Joseph. "Automated infant hearing screening using the ABR: development and validation." American Journal of Audiology 4.2 (1995): 6-14.
   • Nature of Data: Retrospective (referencing historical clinical studies and data from predicate devices) and prospective (new non-clinical bench testing for ALGO 7i).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • For the original ABR template creation (for the predicate ALGO I using 35 neonates), the text does not specify the number of experts. However, it implicitly relies on the clinical expertise and methodologies employed at Massachusetts Eye and Ear Infirmary during the initial development of the ABR technology. No specific number or qualifications of experts are given for establishing the ground truth for the test set of the ALGO 7i, as its "test set" for clinical performance is essentially the historical performance data of the ALGO 3i.

3. Adjudication Method for the Test Set:

   • Not applicable as this was not a comparative clinical study with human readers adjudicating results for the ALGO 7i. The ALGO device itself provides a PASS/REFER/INCOMPLETE result based on its internal algorithm without human adjudication within the device's operation. The source ground truth (the ABR waveforms from the 35 neonates) would have involved clinical expertise, but the specific adjudication method (e.g., 2+1) is not described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done for the ALGO 7i. The device is a standalone automated screener; it is not designed to assist human readers in interpreting results. Its output is a direct PASS/REFER/INCOMPLETE.
   • Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

5. Standalone Performance:

   • Yes, a standalone (algorithm only) performance was done. The ALGO 7i is entirely an algorithm-driven device that provides a direct PASS/REFER/INCOMPLETE result based on its patented signal processing technology and template matching. Its performance is evaluated based on its ability to accurately classify hearing status. The "standalone" performance metrics (sensitivity, specificity, sweeps to result) are those derived from the predicate ALGO 3i, as the ALGO 7i uses the exact same fundamental algorithm.

6. Type of Ground Truth Used:

   • Expert Consensus / Physiological Data: The core ground truth for the ABR template is derived from the "morphology of normal hearing, near-threshold, infant ABR waveforms" determined by superimposing responses from 35 neonates. This implies a physiological ground truth established through clinical observation and interpretation, consistent with expert understanding of normal infant hearing.
   • Outcomes Data: While the original studies for the predicate device would implicitly rely on long-term outcomes to validate the clinical utility of the screening, the immediate ground truth for template development is physiological (ABR waveforms).

7. Sample Size for the Training Set:

   • The "training set" for the algorithm's template was generated from the ABR waveforms of 35 neonates. This serves as the basis for the fixed "template" which the algorithm matches against.

8. How the Ground Truth for the Training Set Was Established:

   • The ground truth for the training set (the ABR template) was established by superimposing the responses of 35 neonates to 35 dBnHL click stimuli. These neonates were presumed to have normal hearing, and their physiological responses (ABR waveforms) formed the "template" against which subsequent readings are compared. This data collection occurred at the Massachusetts Eye and Ear Infirmary during the design and development of the original ALGO device. The process involved collecting actual ABR waveforms from a cohort of what medical experts considered "normal-hearing" infants.

Ask a specific question about this device