Hearing Innovations: What Is Available Now and What Is Still Research

Available now or still research?

• Bluetooth LE Audio — a new generation of Bluetooth audio that also enables Bluetooth hearing aids (Bluetooth SIG). Existing standard; support varies by device.
• Auracast — broadcast from one source to an unlimited number of devices (Bluetooth SIG). Existing standard; rollout in public places varies.
• Hearing-aid mode in earbuds — software for adults with mild to moderate loss (FDA). Authorized in the US in September 2024.
• Deep-neural-network (DNN) noise reduction — signal processing that tries to separate speech from noise (Audiology Research, NIDCD). In research and in devices; evidence still limited.
• Gene therapy (OTOF) — delivering a working gene to the inner ear (The Lancet). Research, not yet an available treatment.
• Hair-cell regeneration — getting the ear to replace lost hair cells (NIDCD). Research, not yet an available treatment.
• Bimodal tinnitus device — sound in the ear plus mild electrical stimulation of the tongue (FDA, NIDCD). Device type classified by the FDA in 2023; not a cure.

Available now: connectivity and earbuds

LE Audio. According to the Bluetooth SIG, LE Audio improves Bluetooth audio performance, adds a new codec called LC3 and enables the development of Bluetooth hearing aids.

Auracast. A Bluetooth broadcast capability: one source can send audio to an unlimited number of devices. The Bluetooth SIG expects it to become the next generation of assistive listening in public places. Both your device and the venue need to support it.

Earbuds with a hearing-aid mode. On 12 September 2024 the FDA authorized the first over-the-counter software of this kind: a software-only medical app for compatible Apple AirPods Pro, for people 18 and over with perceived mild to moderate loss, adjustable without a professional. In the study the FDA reviewed (118 participants), self-fitting gave a perceived benefit similar to professional fitting. This is a US authorization.

Artificial intelligence and noise reduction

NIDCD notes that researchers are applying new signal-processing strategies to hearing aids. One is the deep neural network (DNN), an artificial-intelligence method that tries to separate speech from background noise.

A 2024 study in Audiology Research tested such a program in ten people. In noise, in the lab, speech understanding improved by 20 to 32 percentage points compared with another program. The authors name the small sample as the main limitation, and only one device model was tested, so the result cannot be generalized.

Still research: gene therapy and hair cells

Gene therapy. Research, not yet an available treatment. In 2024 The Lancet published a trial in six children aged 1 to 18 with an inherited deafness linked to the OTOF gene. Hearing improved in five of them, with no serious adverse events. It is a small, early trial in one type of deafness and is not currently relevant to most adults with hearing loss.

Hair-cell regeneration. Research, not yet an available treatment. According to NIDCD, fish and birds can replace damaged hair cells, but humans cannot. Researchers have grown hair cells in the lab; finding drugs that help the ear replace lost cells is still a future goal.

Tinnitus: a new device type

In 2023 the FDA classified a new type of tinnitus device through the De Novo pathway. It combines sound in the ear with external electrical stimulation of sensory nerves, delivered through the tongue. According to the FDA it is intended for temporary relief of symptoms in people 18 and over with at least moderate tinnitus, prescribed by a professional.

Good to know: according to NIDCD there is currently no cure for tinnitus, but there are ways to reduce symptoms. Classifying a device type does not mean it will help everyone.

Key takeaways

• Some innovations are available now; others are still research.
• LE Audio and Auracast are existing standards; rollout varies.
• FDA authorizations are American.
• Gene therapy and hair-cell regeneration are not yet available treatments.
• No device cures tinnitus today.