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World Hearing Day - a sound investment in safety is key

Today is the World Health Organization's World Hearing Day

Hearing aid
Brian joined the product liability team at Leigh Day in 2011 and specialises in claims arising from defective medical devices and drugs. Brian tweets as @mcferran_b.
Today we celebrate World Hearing Day with this year’s theme being “Action for hearing loss: make a sound investment.”

The aim is to draw attention to the economic impact of hearing loss highlighting that prevention, screening for early identification, rehabilitation through hearing devices, captioning and sign language are among the strategies which can mitigate hearing loss and its consequences.

One of the most successful medical interventions is the use of cochlear implants to help people with profound hearing loss. The implant is an electronic medical device which replaces the function of the damaged inner ear and provides sound signals to the brain.  

Cochlear implants are generally reliable and data from manufacturers has shown that the best performing models have very low failure rates of only 7.9% at 26 years. This means that the vast majority of users can expect their implant to provide them with many years of excellent function.

Some implants, however, do fail early and this sometimes necessitates surgery to remove the failed device. Failure of an implant can happen for all sorts of reasons unrelated to the brand or model of the implant, but some models have demonstrated high early failure rates meaning the manufacturer has needed to issue a formal recall. This is can be distressing for patients.

Cochlear implant surgery is invasive surgery under anaesthetic and carries with the normal risks of surgery, including serious infection. Following replacement of the device, the patient has to wait 3-6 weeks before the new implant is turned on and then will have to attend follow-up appointments so the new device can be calibrated.

The majority of people who have approached me for advice in relation to failed implants are parents of very young children with congenital hearing difficulties. Additional surgery and rehabilitation coupled with a many weeks where the child does not have use of their implant can culminate in a very stressful period for both the child and their parents.

In addition, unless the costs are covered by the manufacturer themselves, then the burden of the costs of surgery and follow-up will likely be borne by the NHS.

Cochlear implant surgery is undoubtedly a highly successful procedure generally and has benefited many thousands of people around the world. Patients, and especially children, are entitled to expect a very high level of safety when it comes to these types of medical devices.
I encourage manufacturers to continue to make “sound investment” in safety above all else and make sure they get it right the first time round. When things do go wrong, then the burden of putting things right should fall on the manufacturer and not our health service.

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