The Otologics MET Ossicular Stimulator

The otologics MET* ossicular stimulator

Conventional Hearing Aids

Hearing aids are the primary means of amplifying sound for persons with sensorineural hearing loss. Even though these amplified sounds are louder and can be heard, understanding sounds is still a problem, and understanding speech becomes more difficult as hearing loss increases. Many individuals with moderately severe to severe sensorineural hearing loss express dissatisfaction with conventional air-conduction (acoustic) hearing aids. Specific areas of dissatisfaction include difficulty

Middle Ear Implants

The development of various technologies for MEI that directly stimulate the ossicles has created a new therapy and a new segment of the medical device industry. This new therapy may provide enhanced amplification of sound with improved sound quality for the individual with moderately severe to severe sensorineural hearing impairment. Early anecdotal results from all participants in this field claim that this class of device may substantially benefit a segment of the hearing-impaired population.

Otologics MET Ossicular Stimulator

An implantable hearing device seems a logical progression in the development of hearing device technology. The purpose of such a device is to eliminate the receiver and drive the ossicles directly to eliminate occlusion of the outer ear canal, improve sound quality, and provide greater gain without feedback for optimal speech recognition. The MET Ossicular Stimulator (Otologics, LLC., Boulder, CO) was designed specifically with these goals in mind (“MET” stands for Middle Ear Transducer).

The

Met Ossicular Stimulator Preclinicalresearch and Development

Otologics, LLC, in conjunction with Dr. John Fredrickson at the Washington University School of Medicine in St. Louis, Missouri, developed the current MET Ossicular Stimulator and has started a Food and Drug Administration (FDA)–approved clinical study with the device. Preclinical research conducted over the course of 18 years considered both the safety and efficacy of the device.

Specifically, in regard to safety, the primary objectives were

• •

  Biocompatibility of the materials used in the

The Met Ossicular Stimulator Surgery

The implantation of the MET Ossicular Stimulator takes about 2 hours and can be performed as an out-patient procedure, at the surgeon's discretion. Under general anesthesia, an atticotomy is performed with a 6-mm burr starting at a 12 o'clock position superior to the bony external ear canal at the root of the zygoma (Fig. 5). This 12 o'clock position is defined by extending a vertical tangent up from the anterior canal wall. The atticotomy can be extended as needed anteriorly to expose the head

The Met Ossicular Stimulator Clinical Study

The MET Ossicular Stimulator is currently in a phase II multicenter FDA-approved clinical study in the United States. Concurrent clinical trials are also being conducted in Europe and Japan.

The objective of the clinical study is to determine the safety and effectiveness of the implanted mechanical device combined with the external processor. Patients are screened, based on available audiometric records, and selected candidates are given a thorough medical and audiologic evaluation (Fig. 9).

Summary

Early preclinical research demonstrated that the MET Ossicular Stimulator can effectively benefit patients with moderately severe to severe sensorineural hearing loss. The MET Ossicular Stimulator is now in an FDA-approved clinical study. To demonstrate benefit over conventional hearing aids, the MET Ossicular Stimulator is compared with state-of-the-art digital conventional hearings aids using the same signal processing programs. The device program and performance are then verified in the