FOOTHILL RANCH, Calif.—iBASEt recently announced that Earlens Corporation, Inc., a Silicon Valley-based medical technology company that has created a unique light-driven hearing aid, will implement iBASEt’s Solumina software as its manufacturing execution system (MES).
Unlike conventional hearing aids, Earlens is pioneering a fundamentally new design using light and a small lens placed in the ear, to create a rich, natural sound and deliver what it calls the broadest frequency range of any hearing aid on the market.
Earlens has created a manufacturing infrastructure using 3D printing to improve design flexibility and support faster time-to-market. Solumina will be installed at the company’s corporate headquarters in Menlo Park, California, to manage production in this environment while focusing on quality control and cost efficiency.
“We are excited to work with iBASEt to put in place an innovative technology manufacturing infrastructure,” said Mark Bishop, vice president of operations for Earlens, in a press release. “We believe it is a smart move for us to implement an MES/QMS solution now, in the early stages of our business, so that we can rapidly scale production to meet growing demand for our product and keep pace with design changes and improvements.”
Working with iBASEt, Earlens will put in place the necessary systems to manufacture its innovative new product, while improving the average completed device lead time and quality of data entry. The manufacturing system will reduce batch file administration efforts of electronic device history records (eDHR), which keep a full record of the products produced to ensure quality and compliance with 21 CFR Part 11 and Part 820 throughout the process, iBASEt reported. Solumina is also expected to help increase product yields and provide visibility into current work order status by manufacturing supervisors and office personnel.
“Additive manufacturing, using 3D printing technology, is a fundamentally new approach that offers manufacturers a number of advantages over traditional methods for better design flexibility, time to market, and cost control,” said Vic Sial, president of iBASEt, in the release. “We appreciate the confidence Earlens has placed in iBASEt by choosing our software and team of experts to put in place the innovative manufacturing infrastructure the company needs to manage production, streamline operations, and meet changing design and regulatory requirements.”
Earlens Corporation (earlens.com), a privately held medical device company headquartered in Menlo Park, California, has developed the Earlens Light-Driven Hearing Aid, reported to be the first hearing device to use light to transmit sound. In late 2015, the FDA granted a De Novo allowing Earlens to market its Light-Driven Hearing Aid.
IBASEt (ibaset.com) provides software to complex, highly regulated industries, such as aerospace and defense, medical devices, nuclear, industrial equipment, electronics, and shipbuilding. The company is based in Foothill Ranch, California.