Technical data and terms can feel overwhelming at first. However, the technology isn’t as complicated as it may sound and as you’re the person who’s going to live with your implant for at least the next 20 years, don’t be tempted to let someone make the product choices for you.
Understanding reliability data
The long-term reliability of your implant is important, because you’ll need surgery to replace your implant if it fails completely. All the companies have to produce product reliability data, which should comply with ISO 5841-2: 2000, the official industry standard. However, this is tailored to cardiac pacemakers and is interpreted by each hearing implant manufacturer in a different way, making data comparisons between companies challenging. A new standardisation approach is on its way in the US, but until then, the most important thing when comparing data between companies is to check that you’re comparing like with like. For the most accurate results, here’s what to look out for:
There should be a comparable number of products in use in each of the different studies.
The studies should cover the same time frames – it’s not appropriate to compare the failure rate of one device over a five-year period with another over a 20-year period.
The data for all the products being compared should be for the current time period.
The product generations of each brand should be similar.
The same failure categories need to be used for each brand – for instance technical failures should be compared only with technical failures and not with technical and medical failures. Data should also include the total number of devices that have been removed.
Other ways to assess reliability
If you’re finding it difficult to determine certain details from company data, call each company and ask to speak to a professional who can explain the research.
Ask medical professionals for details of impartial studies on product reliability and how to interpret them. You may also be able to find short summaries of studies, known as abstracts, on online databases such as PubMed and sometimes the whole publication is available free from the publisher’s website. However, they are written for medical professionals, so may be difficult to interpret. Ask a medical professional to help if necessary.
Check clinics’ websites for reliability reports.
Look at private websites that publish reliability comparisons. There’s a growing number, such as 2ears2hear that take information from manufacturers and clinics and present it in a clear and accessible way for a non-medical audience. However, do check who the website is run by first. All good websites have an ‘About’ section.