From Vibration to Sound: Active Implants Treating Hearing Loss

Today, it's estimated that 10% of the US population will undergo a procedure to have a medical device implanted within their bodies at some stage in their lifetime. To grasp the latest advancements in hearing implants, it is crucial to distinguish between passive and active implant technologies.Passive implants are innovative medical devices implanted in the body that operate independently without an external power source. Crafted from durable materials such as metal or plastic, these implants are tailored to enhance or substitute biological components. Stents, dental implants, traditional bone-anchored hearing aids, and hip prostheses are some common examples. The rich history of passive implants dates back thousands of years, with dental implants being a prominent example.

Active implants, also known as Active Implantable Medical Devices (AIMDs) or simply "active implantables" are medical devices that require an external power source to operate. These devices are surgically or medically introduced into the body and are intended to stay there for an extended period. Active implants have been around for several decades and are partially or completely inserted into the human body to provide diagnostic or therapeutic benefits. Some common examples of active implants include cardiac pacemakers, neurostimulators, and implantable defibrillators.

Active Implants Treating Hearing Loss

Advancements in active implanted hearing devices have revolutionized the treatment of different types of hearing loss, providing innovative solutions for individuals who face challenges with traditional hearing aids or find them inadequate.

The introduction of fully implanted active middle ear implants has opened up new possibilities for adults with sensorineural hearing loss, offering a treatment option that surpasses the limitations of many external options. Fully implanted technology provides continuous access to hearing, allowing individuals to experience sound round-the-clock, even during the night. Nighttime hearing is crucial for everyone, but it's especially vital for caregivers or those living independently who rely on auditory support for their safety and well-being after dark.  People with sensorineural hearing loss encounter further obstacles as they grow older, including issues with dexterity, vision impairments, or cognitive conditions like dementia, which can complicate the use of traditional hearing aids. Moreover, individuals with active lifestyles may find wearing a hearing aid in their ears uncomfortable or impractical.

The Esteem® active middle ear implant is the sole FDA-approved fully implanted active middle ear implant (FI-AMEI) available commercially.  Unlike conventional hearing aids, the Esteem leverages the ear's natural structure to capture sound without a microphone. The Esteem implant utilizes a novel piezoelectric sensor to detect and transform the natural vibrations of the eardrum in response to sound waves into electrical signals, effectively using the patient's own eardrum as the microphone and allowing for an open ear canal.

Active bone conduction implants use magnetic technology to transmit sound vibrations directly to the inner ear through the skull. These devices are beneficial for individuals experiencing conductive or mixed hearing loss. They employ an external sound processor to capture and process sounds, along with an internal implant that transmits vibrations directly to the inner ear.

Cochlear implants have also embraced technological progress, now featuring Bluetooth connectivity for telemedicine and remote rehabilitation options. Research is focusing on investigational, fully implanted versions. Cochlear implants directly stimulate the auditory nerve by bypassing damaged ear parts. Traditional cochlear implants are partially implanted using an external microphone, speech processor, transmitter, and an implanted receiver-stimulator connected to an electrode array within the cochlea. The microphone captures sound, undergoes meticulous processing to convert it into electrical signals, and stimulates the auditory nerve, enabling sound perception by the brain. Cochlear implants are designed for people with moderate to profound sensorineural hearing loss who struggle with understanding words.

Fortunately, we have gained valuable insights from the advancements in active implantables, allowing us to build upon that foundation and drive new innovations. The prevalence of active implants in hearing devices is on the rise, and our commitment to innovation is starting to have a significant impact on the possibilities in this field.

Just this week the Senate introduced bipartisan bill S.4829 The Hearing Device Coverage Clarification Act which seeks to clarify that fully implanted medical devices are prosthetics and not subject to the current hearing aid coverage exclusion.

Help Support the Hearing Device Coverage Clarification Act here!