Invisible cochlear implants: cost, surgery, and innovation

An invisible cochlear implant is a fully implanted hearing device designed to be entirely concealed under the skin. Unlike traditional cochlear implants, which have an external sound processor that is visible behind the ear, invisible cochlear implants are composed of fully internal components, including the sound processor, microphone, and battery. This configuration allows users to enjoy discreet hearing assistance, free from the visibility of traditional hearing aids or cochlear implants.

The purpose of the invisible cochlear implant is not only to address the functionality of hearing loss solutions but also to address social and psychological factors. Many individuals are self-conscious about wearing visible devices, especially younger patients or those in professional settings. With invisible implants, these users can experience sound restoration without the aesthetic challenges that traditional devices may present.

• Limited Availability and Eligibility: Invisible cochlear implants are still relatively new and under development, meaning they are currently available only to select candidates in clinical trials. Strict medical and anatomical requirements can limit eligibility.
• Higher Surgical Complexity: Since all components are implanted internally, the procedure to place an invisible cochlear implant is more complex than traditional implants. This can increase surgery time, recovery duration, and possibly the risk of complications.
• Potential Cost and Accessibility Barriers: Due to their advanced design and limited availability, invisible cochlear implants may come with a higher cost, which could pose a barrier for some individuals without adequate insurance coverage or financial support.
• Long-Term Battery and Upgrade Challenges: Since the internal device cannot be accessed easily, battery life and upgrades may require additional surgeries. This could impact users’ convenience and incur additional costs or healthcare visits over time.

Invisible cochlear implants differ significantly from traditional cochlear implants in both appearance and maintenance. Here are the main distinctions:

• Visibility: Traditional cochlear implants consist of an external sound processor worn behind the ear, connected magnetically to an internal component. In contrast, invisible cochlear implants are entirely concealed, making them unnoticeable from the outside.
• Maintenance and Battery Life: Traditional cochlear implants require daily charging and cleaning, while invisible cochlear implants, with their long-lasting implanted batteries, eliminate the need for daily maintenance.
• Natural Sound Capture: The positioning of the invisible cochlear implant components within the ear allows for a more natural capture and processing of sounds, providing an experience that many users find closer to natural hearing.

Invisible cochlear implants are particularly suitable for individuals who lead active lifestyles, as they do not require users to wear or recharge external components. Additionally, they are waterproof and resistant to daily wear, making them ideal for continuous use without the limitations of traditional models.

When it comes to implantable hearing solutions, both Bone Anchored Hearing Aids (BAHA) and cochlear implants are effective options for specific types of hearing loss, but they serve different purposes and mechanisms.

• BAHA devices are designed for individuals with conductive or mixed hearing loss, where sound conduction through the outer or middle ear is limited. BAHA bypasses the ear canal and middle ear entirely, using bone conduction to transmit sound vibrations directly to the inner ear.
• Cochlear implants, on the other hand, are intended for those with severe to profound sensorineural hearing loss. These devices bypass damaged hair cells in the cochlea to directly stimulate the auditory nerve, allowing the brain to interpret sound.

While both implants improve hearing, the choice between BAHA and cochlear implants depends on the type and severity of hearing loss, as well as the specific needs and anatomy of the patient. Consulting with an audiologist or ENT specialist can help determine which option is the most suitable.

Invisible cochlear implants work by converting sound vibrations into electrical signals, which are transmitted directly to the auditory nerve. This process involves several components that are surgically implanted in the inner ear and skull. Unlike external hearing aids, which amplify sounds, cochlear implants, including invisible models, bypass damaged parts of the ear to directly stimulate the auditory nerve.

The key components of an invisible cochlear implant system include:

• Microphone: Captures sound from the environment.
• Sound Processor: Converts sound into electrical signals.
• Electrodes: Stimulate the auditory nerve with electrical impulses.
• Battery: Powers the entire device, designed to last several years without the need for frequent recharging or replacement.

With these internal components, invisible cochlear implants can offer a near-natural hearing experience, capturing sounds in a way that mimics the ear’s natural mechanisms.

The surgery for an invisible cochlear implant is similar to that of a traditional cochlear implant but with a few added steps due to the internalization of all components. The procedure involves implanting the device’s components beneath the skin and connecting them to the cochlea and auditory nerve. Here is an overview of what the surgery entails:

• Preparation and Evaluation: Before the surgery, patients undergo extensive testing, including hearing assessments, imaging scans, and consultations with an audiologist and a surgeon. These evaluations help determine if the patient is a suitable candidate for an invisible cochlear implant.
• Implantation Process: During the procedure, the surgeon creates a small incision behind the ear and drills a pathway to the cochlea. The electrodes are carefully inserted into the cochlea to stimulate the auditory nerve, while the sound processor, microphone, and battery are placed beneath the skin, generally near the ear or upper neck.
• Recovery: The recovery process can take several weeks, during which the patient’s body adapts to the implant. Post-surgery, patients work with audiologists to fine-tune the settings and learn to interpret sounds through the new device.
• Follow-Up and Rehabilitation: Invisible cochlear implants require follow-up sessions to monitor hearing progress and ensure the device is functioning optimally. Rehabilitation often includes auditory therapy to help patients adjust to the electrical stimulation of their auditory nerve.

While the surgery is generally safe, like all surgical procedures, it carries some risks, including infection, dizziness, and changes in taste. However, with proper care and follow-up, most patients recover well and adapt to their new hearing device.

Currently, invisible cochlear implants are available through clinical trials as researchers gather data on their long-term effectiveness and safety. Notably, the Acclaim Cochlear Implant by Envoy Medical received FDA approval for clinical trials and has shown promising results. The trial phase is crucial for obtaining regulatory approval, which would eventually make invisible cochlear implants more widely accessible.

These clinical trials are generally conducted at specialized hearing centers and involve strict eligibility criteria. Participants often undergo comprehensive evaluations before being approved for the trial and receive extensive post-operative monitoring. These trials provide valuable insights into the device’s performance and may help shape the future of invisible cochlear implants.

Patients interested in participating in a trial for invisible cochlear implants should consult with an audiologist or hearing specialist to discuss eligibility and locate trial centers.

Research is ongoing into new technologies that may one day replace cochlear implants, including gene therapy, neural prosthetics, and advanced sound processing devices. These innovations aim to restore hearing in different ways, such as targeting the underlying causes of hearing loss or enhancing the brain's ability to process sound without the need for surgical implants.