Developer of biomaterials and customized implants

Developer of AI Platform for Neurological and Psychiatric Disorders Treatment

Harvard University

U.S. Food and Drug Administration
According to foreign media outlet New Atlas, tympanic membrane perforation can cause pain and hearing loss, and its repair is quite complicated.PhonoGraft, developed by Harvard University scientists, is a3D Printingimplant, which can repair damage by "encouraging" natural cell regeneration, has now entered commercial production.
The tympanic membrane, commonly known as the eardrum, is a thin, circular piece of tissue that vibrates in response to sound waves and converts them into electrical signals that the brain can interpret. However, if it is perforated by a foreign body such as a cotton swab or damaged by extremely loud noise, it will fail to perform this function effectively. Worse still, if this barrier is compromised, viruses and bacteria can enter the inner ear, causing severe infections.
Currently, the best treatment is tympanoplasty, which involves repair using an autologous tissue graft. However, the resulting membrane does not conduct sound as effectively as a healthy tympanic membrane. The procedure requires an incision behind the ear and frequently fails, often necessitating revision surgery.
PhonoGraft was designed to address these challenges. The implant mimics the complex shape of the native tympanic membrane, features a bicycle wheel-like "spoke" pattern, and is fabricated from a specially developed synthetic polymer-based...3D PrintingMade from ink. The implant itself not only restores hearing but also provides a scaffold for the regeneration of the recipient's own cells. Tests conducted on chinchillas have proven promising, as their ear anatomy and hearing range are similar to those of humans.
“Three months after implanting our optimized graft into the chinchilla’s ear, we experienced a true ‘Eureka moment,’” said Aaron Remenschneider, a researcher on the project. “Hearing tests demonstrated that sound conduction had been fully restored, which had long been a major hurdle. Then, for the first time, we used an endoscope to examine the ear canal. All we saw was merely a slight remnant of our graft that had been replaced by new tissue—a beautifully reconstructed tympanic membrane with its radial circular pattern.”
As an additional benefit, PhonoGraft can be inserted through the ear canal, making the procedure less invasive.
To commercialize this device, the Wyss Institute at Harvard University launched a startup named Beacon Bio, which was recently acquired by Desktop Health—evidently, this step facilitates its market entry. The team is now working to secure U.S. Food and Drug Administration (FDA) approval to bring PhonoGraft to human patients. Other similar implants are also under development, such as Australia's ClearDrum.
(Editor: admin)