THE BEAT

Companies & technology

The businesses, devices, filings, and product changes behind the specialty, with issuer claims attributed.

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REFERENCES OBSERVED Oct 16, 2026

AccessGUDID flags do not supply production-identifier values

FDA’s catalog stores one portion of a UDI and flags attributes of another.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

OtoCompanion’s record describes an adjunctive image-analysis workflow

A September clearance describes pediatric middle-ear-fluid software with a clinician retained in the workflow.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

SEER preprint separates emotion labels from intensity labels

Its reference-selection method uses emotion supervision and simulated implant processing.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

Preprint proposes single-voice EEG attention tracking

The abstract specifies inputs and labeling assumptions; full methods remain unappraised.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

SoundBubble-EEG preprint uses simulated listening scenes

An auditory-attention EEG preprint uses laboratory scenarios and a fixed block order.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

What “dry” and “wireless” mean in an ultrasonic earpiece preprint

A prototype separates an acoustic ear interface from its control link, while its authors leave physiological testing for future work.

References observed: Oct 16, 2026 ↗

REFERENCES OBSERVED Oct 16, 2026

Bicara’s study record adds six coded U.S. entries

The registry list grew from one entry to seven between retained observations; generic site codes leave institutional identities and activation dates unresolved.

References observed: Oct 16, 2026 ↗

FRAMEWORK EFFECTIVE Sep 10, 2026

FDA’s September 10, 2026 ENT order codified a 2023 decision

FDA’s September 2026 codification and Galen’s July 2023 grant answer different regulatory questions.

Framework effective: Sep 10, 2026 ↗

REFERENCES OBSERVED Oct 15, 2026

Preprint tests speaker video in experimental hearing-aid processing

The laboratory model combines speaker video and an audiogram with audio; wearable processing remains unresolved.

References observed: Oct 15, 2026 ↗

REFERENCES OBSERVED Oct 15, 2026

The gap between NeuroToken’s trial decisions and changing attention

The September preprint combines several decoding tasks. Its stated limitations leave changing attention and clinical use outside the demonstrated scope.

References observed: Oct 15, 2026 ↗

SOURCE ANNOUNCEMENT Oct 13, 2026

Auditory attention preprint tests which inputs drive a model's decisions

The authors propose separate checks of a model's input streams.

Source announcement: Oct 13, 2026 ↗

REFERENCES OBSERVED Oct 15, 2026

Why MAUDE report counts are not device-risk rates

For ENT-device readers, the key checks are what a chart counted, the missing device-use denominator and whether the evidence supports a comparison.

References observed: Oct 15, 2026 ↗

REFERENCES OBSERVED Oct 14, 2026

How to read FDA device milestones in ENT news

FDA's process descriptions distinguish staged PMA submissions, Breakthrough designation and a marketing decision. Each establishes something different.

References observed: Oct 14, 2026 ↗

FRAMEWORK EFFECTIVE Oct 17, 2022