Symphonix Announces Closing of Operations
San Jose, Calif Symphonix Devices Inc announced in mid-November that it would close its doors due to the slow adoption of its middle ear implant technology. The companys board of directors unanimously deemed advisable the dissolution of the company and approved a plan of complete liquidation and dissolution of its business. The company says it made the decision after an unsuccessful process of pursuing strategic alternatives, including potential partner arrangements and a sale of the company outright.
The Vibrant Soundbridge consists of an external audioprocessor and a surgically implanted VORP.
The slow market adoption of the Vibrant Soundbridge combined with the difficult current financing environment has led us to make this very difficult decision, says Kirk Davis, CEO and a company director. However, upon careful consideration from our directors, officers, and advisors, we believe that this action is in the best interests of our stockholders. Symphonix expects to submit the plan of complete liquidation and dissolution of its business to stockholders for approval at a special meeting of the stockholders to be held on a future date.
Symphonix developed, manufactured and marketed the Vibrant Soundbridge, one of the first semi-implantable middle ear implants developed for hearing loss and approved by the US Food and Drug Administration (FDA). The Soundbridge consists of two components, one implanted in the middle ear and the other worn like a BTE hearing aid. The surgically implanted portion is designed to leave the ear canal open and unobstructed, and has been recommended for mild-to-severe sensorineural hearing loss.
The internal component, called the Vibrating Ossicular Prosthesis (VORP), consists of a receiving coil, internal magnet, demodulator, conductor link and the Floating Mass Transducer (FMT), all of which are encased in silicone elastomer. The FMT, which is the size of a grain of rice, is an electromagnetic transducer that is attached to the long process of the incus, positioned at the incudostapedial joint, via a titanium attachment clip. This technology mechanically vibrates the ossicular chain by mimicking the natural frequency response of the human ear to sound. The external component, or Audio Processor, is about the size of five quarters, stacked on top of each other, and is worn behind the pinna, covered by hair. It is held in place by magnetic attraction to the implanted magnet in the receiver portion of the VORP. The device is designed to vibrate the small bones in the middle ear, enhancing the natural hearing process. It is programmed using Siemens PC-based CONNEXX fitting software.
Soundbridge products were marketed in the US by Symphonix, and in Europe in conjunction with Siemens Audiologische Technik in Germany. Recently, the company announced that the Department of Defense had validated treatment and approved coverage for the implant for military personnel. However, in late October, Symphonix reported that their net losses for the nine months ended September 30 were $5.7 million. Revenue for the nine months ended September 30, 2002 were $1.4 million compared to $1.5 million during the same period of 2001.
Oticon Takes Grand Prize in Information Society Awards
Somerset, NJ Oticons Adapto hearing instrument took top honors as a grand prize winner in the 2003 European Information Society Technology Prize, reportedly one of the worlds most distinguished awards for groundbreaking information technologies. Over 437 companies from 27 countries competed in this years international awards program.
Oticon CEO Niels Jacobsen accepts the Grand Prize trophy for Adapto at the European Information Society Technology Awards. He is joined on stage by Jes Olsen, the companys Director of Business and Product Development.
We are honored to have this innovative hearing instrument recognized by so prestigious an organization as the European Information Society, says Mikael Worning, president of Oticon, Inc. We are especially pleased that Adapto is seen as an instrument that facilitates the sharing of information. We know that Adaptos ability to enhance users abilities to communicate with family, friends, and colleagues has been key to its success in the marketplace.
The Adapto was honored for its technical excellence, innovative content, potential market value, and resulting capacity to generate new jobs, according to Oticon. The new instruments VoiceFinder technology is designed to immediately detect human voice sounds and process them for better understanding. If no speech is detected, the device is said to automatically switch to a comfort mode that tunes out noise and irrelevant sounds, protecting users from the fatigue that constant unfiltered sounds can inflict on hearing instrument wearers.
To meet customer demand for Adapto and other new products introduced in 2002, Oticon now employs two shifts of technicians who keep production moving 16 hours per day. The company reports that it is currently expanding its Somerset facilities to include a new 15,000-square-foot state-of-the-art laboratory and testing facility. The company has also recently earned certification from the International Standards Organization (ISO) for its quality management systems.
Senate Confirms McClellan as New FDA Commissioner
Washington, DC The US Senates unanimous confirmation of Mark McClellan, MD/PhD, ended the US Food and Drug Administrations (FDA) longest period without a commissioner (21 months). The 39-year-old physician and economist was formerly an associate professor of economics and medicine at Stanford University before joining the White House Council of Economic Advisors. Prior to McClellan’s confirmation, FDAs longest stint without a commissioner was the 20 months between the departure of David Kessler and the swearing-in of Jane Henney.
The office of FDA commissioner is of particular interest to the hearing industry, as the commissioner has wide control over regulatory initiatives relative to the manufacturing, marketing, and dispensing of hearing instruments. The appointment of David Kessler and the December 1993 public hearings that took place during the proposed revision of the Hearing Aid Rule led to a period of industry upheavalmany still believe that Dr. Kessler was at least partially responsible for the depressed industry sales in the mid-90s.
There is little in Dr. McClellans history to suggest that he will place any particular emphasis on the hearing industry or regulation concerning the dispensing of hearing instruments. Issues that the new commissioner has waiting for him revolve mainly around the ongoing reorganization and merger of the Center for Drug Evaluation & Research and Center for Biologics Evaluation & Research, approval times and fee structures for new pharmaceuticals and devices, and food and consumer safety issues.
Siemens Hosts International Symposia in Hungary and Australia
Piscataway, NJ Siemens Hearing Instruments recently hosted two international symposia for dispensing professionals around the world. About 440 hearing care professionals attended the 13th and 14th International Symposiums held in Budapest, Hungary, and Port Douglas, Australia, respectively.
Symposium attendees participated in hands-on sessions with the newest advanced digital hearing instruments and programming software, hearing care practice software, and other related equipment for hearing care solutions. This years educational program featured Siemens’ latest directional microphone technology, including the TriMic hearing instruments, the companys new three-microphone directional technology. Participants in the symposiums received continuing education credits from the American Speech-Language-Hearing Association (ASHA), American Academy of Audiology (AAA), and the National Institute for Hearing Instruments Studies (IIHIS).
Good Housekeeping Presents Award to Phonak
Warrenville, Ill Phonak was recently announced as the grand-prize winner of the first annual Marketer of the Year Award presented by Good Housekeeping. Companies who have earned the Good Housekeeping Seal, as Phonak did in August 2001, were eligible to compete in the contest.
The award recognizes companies that have best leveraged the value of the Good Housekeeping Seal to help market and promote their products. Phonak and the three honorable-mention recipientsAristokraft cabinets, Lennox heating and cooling systems, and Clopay garage doorswere honored at a special reception in the Good Housekeeping Dining Room in New York City.
Phonak was honored by Good Housekeeping for both the creativity and effectiveness of its advertising with the Seal. As the grand-prize winner, the company receives a free full-page advertisement in an upcoming issue of Good Housekeeping magazine which reaches 25 million readers every month. The Good Housekeeping Institute, founded in 1900, is a consumer product testing facility that evaluates products appearing in the magazines articles and advertisements.
Hearing Components Receives VA Contract for Snap Tip Earmold
Oakdale, Minn Hearing Components Inc has been awarded a one-year contract, with an extension option for up to three years, from the Department of Veterans Affairs (VA) to supply the Comply Snap Tip Earmold System, according to the company. The system is designed to replace custom earmolds, connecting BTE hearing instruments to the ear canal.
The contract will have significant monetary and labor savings for the VA, says Hearing Components Director of Marketing Joe Romeo. The costs of servicing earmolds can be cut significantly, freeing more time and resources to see more patients, and reducing appointment-scheduling backlogs.
Hearing Components conducts research and development on the ear canal, and recently introduced Comply Snap Tips, the latest in the companys compliant earmold technology. The VA also awarded the company contracts for Comply Canal Tips, Comply Soft Wraps, Ad·hear Cerumen Guards, and Ad·hearPlus Cerumen Guards, according to the company.
Advanced Cochlear Systems Obtains Patent and NIH Grant
Snoqualmie, Wash Advanced Cochlear Systems (ACS) has been awarded a patent for its new cochlear implant (CI) technology, and the company has procured a Phase II grant from the National Institutes of Health (NIH) to continue its research on a new electrode array that the company says could improve hearing performance, reduce manufacturing costs, and potentially lead to binaural implantation of CIs.
The company reported that they expected the patent, titled A Method for the Real-Time Transformation of an Electrical Signal Representative of a Waveform, to be issued in November 2002. This patent protects ACS proprietary technology that focuses on enabling different sound frequencies to stimulate distinct regions of the cochlea in a way that is designed to mimic natural hearing more closely than cochlear implants currently on the market, according to the company. The technology is also said to preserve the exact timing of sound waves, providing the foundation for the development of binaural cochlear implants.
For the past two decades, the development of cochlear implant technology has been limited to a series of small incremental steps, says ACS President John Hrobsky. This patent represents a major advance in how we address hearing loss and is the first component of our new generation of cochlear implant technology. The technology that ACS is pursuing, including three other patents for which we have applied, is designed to markedly increase speech recognition, especially in noisy environments, and enable hearing-impaired individuals to appreciate music and other sounds associated with lifes daily activities.
Cochlear implants substitute a tiny electrode array for the hair cells, but current implant technology stimulates less than 22 sites, one site at a time, within the cochlea. ACS contends that this limited amount of information makes it difficult to identify many spoken words and everyday sounds without additional aids, such as context or lip reading. The electrode being developed by the company is reportedly capable of simultaneously stimulating multiple sites within the cochlea, providing significantly more speech signal information and enhancing the perception of music and other sounds.
People with normal hearing can determine the location of a sound because the sound waves arrive at each ear at slightly different times. Current cochlear implants, which are normally used in only one ear, do not preserve the exact timing of a sound wave and cannot provide this important spatial information, according to ACS. The preservation of the timing information is designed to make it possible for people with CIs in both ears to localize the direction from which sound is coming. If approved for binaural use, this technology could provide stereo hearing for implant recipients.
ACS also announced that it received a $750,000 Small Business Innovation Research (SBIR) Phase II grant from NIH to continue the development of a high-density electrode capable of delivering discrete electrical stimuli to more than three times the number of sites within the cochlea that current technology provides. The electrode will be manufactured using proprietary, advanced micro-electromechanical techniques that are expected to significantly reduce manufacturing costs compared to the manual assembly required by existing electrode technology.
The first phase of the grant, received by ACS in July 2000, resulted in the assembly and testing of several different prototype electrodes. The most promising designs are the subject of the Phase II grant. ACS reports that it has previously received five SBIR grants covering other technology components of its cochlear implant system. These grants are awarded to small businesses that engage in research and development and have the potential for commercialization. Phase II grants are awarded only after technical merit and feasibility of the project have been established in Phase I.
ACS says that approval of bilateral implants could double the current cochlear implant market size, currently estimated at about $250 million annually worldwide, with a forecasted growth rate of 20% per year.
In the November 2002 article on the International Hearing Societys (IHS) annual convention (pages 57-58), an error occurred relative to the attendance figure; there were an estimated 650 hearing care professionals present at the convention. Additionally, IHS Government Relations Representative Karen Sealanders name was misspelled. HR regrets these errors.