Hearing loss, a severe form of deafness, affects millions of individuals worldwide. Genetic mutations and familial Hearing impairment account for 50% to 60% of cases. It’s estimated that by 2050, around 700 million people will require some form of intervention for hearing loss globally, such as hearing aid devices. Despite being an invisible disability, hearing loss has significant negative social effects, leading to increased social isolation and reduced overall quality of life. While hearing aid devices remain a primary treatment option, clinical researchers, biotech sponsors, and contract research organizations (CROs) are developing new medical devices and techniques which could become widely accessible in the future.

In this article, we will explore the latest advancements in hearing loss interventions, focusing on emerging technologies and medical device clinical trials that have the potential to revolutionize the field of hearing aid devices.

Advancements in Today’s Hearing Aid Technology

Surgery and medical devices like conventional or implantable hearing aid devices have proven effective in reversing most cases of conductive hearing loss. However, for sensorineural hearing loss (SNHL), which involves damage to the cochlea or spiral ganglion, surgical options are limited, but bone-anchored hearing aids (BAHAs) and cochlear implants can be considered. Whereas BAHAs transmit sound input into bone vibrations which stimulate inner ear hair cells, cochlear implants consist of a processor that transforms sound signals into a digital signal, which is then sent to the brain. While physical hearing devices have made significant progress in terms of customization, they still offer limited assistance to individuals with severe impairments. To address this, sponsors are developing medical devices that incorporate advancements in regenerative therapy, precision medicine, and artificial intelligence (AI) with the support of medical device CROs.

1 | Regenerative Therapy

Regenerative therapy draws inspiration from the regenerative capabilities of birds, reptiles, and amphibians, which can restore their hearing function by regenerating hair cells. Scientists have primarily explored manipulating the undifferentiated stem cells of a patient’s own ear to repair damaged hair cells, but this approach is still in the preclinical stages of drug development and early-phase medical device trials. However, Frequency Therapeutics has recently been testing an intratympanic compound to stimulate progenitor cells into becoming hair cells in SNHL patients. The preliminary results demonstrated significant improvements in speech perception. Their phase II placebo-controlled clinical trial (NCT05086276) has finished recruiting as of March 2023 and the results are expected to become available by 2024.

2 | Precision Medicine and Gene Therapy

The heterogeneity of hearing loss, with various phenotypes and underlying genetic causes, poses challenges to efficient diagnosis and treatment using standard hearing aids, particularly in severe cases of SNHL. However, these challenges are well-suited to precision medicine, which is becoming more commonplace with advances in next-generation sequencing (NGS) and better analysis of patient data. With the creation of large biobanks and case repositories, NGS and other genetic sequencing tools have been able to identify several genes related to hereditary deafness. Current methods in inner ear gene therapy are targeting these mutations by using the easy surgical accessibility of cochlear implants to deliver viral and non-viral vectors for gene replacement, silencing, and amplification. These approaches, along with molecular genetic testing, are expected to play important roles in the future for individualized diagnosis and treatment of hearing loss.

3 | Machine Learning and Big Data

The evolution of deep learning algorithms has enabled better characterization of severe SNHL, not only as a dysfunction of the inner ear, but also as an extension of neurological gene dysfunction. This approach is rooted in AI being used to profile a significant array of hearing and hearing-related patient data and determine patterns of association between cochlear implant success and individuals with certain characteristics. The inner ear varies in its shape from person to person and for the implant to have the desired outcome, the patient in question must also have intact auditory pathways and signal processing capacity. Personalized approaches using database-driven profiling can help ensure cochlear implants are designed with the right electrode length for optimal fit and coverage of remaining hair cells for each individual.

Blending Medical Discovery with Technology

Despite the availability of interventions, at least 85% of hearing-impaired individuals remain untreated in the United States. Not only is there an existing stigma, but concerns about efficacy, cost, and comfort are contributing to their low usage; however, using personalized medicine approaches to address the heterogeneity of hearing loss may help overcome these barriers. Rehabilitation options built around stem cell regeneration, genomic sequencing, and AI-driven biobank profiling could present valuable alternative treatments for patients with severe hearing impairment in the future.

Partner with Vial Medical Device CRO

Vial is a full-service CRO that recognizes the crucial role of technology in gaining a deeper understanding of complex diseases like genetic and age-related hearing loss. Trusted by leading sponsors, our specialized teams are paving the way for modernized clinical research by leveraging digital innovation to deliver shorter study timelines, quality, affordable services, and a clinical trial experience that puts you first. Contact a team member today to discover how we can help you advance your medical device through efficient and reliable clinical trials.