A 'catalogue of errors' in the treatment of children with hearing difficulties will have a lasting impact on patients, a report found.
An independent review into paediatric audiology at NHS Lothian found there were failures and ongoing risks in the service over a period of nine years.
The failings led to several profoundly deaf children being diagnosed too late for vital implant surgery.
The Scottish Government said families identified as being directly affected have been contacted to discuss the care their child received and repeat testing and assessment is taking place "where appropriate". A dedicated helpline has also been set up.
The investigation uncovered "significant failures" involving 155 children over a period of nine years.
It follows a case, referred to the Scottish Public Services Ombudman (SPSO), where a child born with hearing loss was not properly diagnosed until the age of nine despite the concerns of their parents and teachers.
The delay caused by NHS Lothian’s repeated failure to assess the child’s condition accurately or to listen to their worried family meant the child missed out on the opportunity to use hearing aids and learn to speak.
The health board was ordered to arrange an independent review of patients whose hearing was tested by their service over a nine-year period to ensure other hearing impairments have not been missed.
The report was led by the British Academy of Audiology (BAA), which looked at 1,113 patient records from 2009-2018 and found "significant failures" in almost 14% of them. Among these 155 children, auditors found five who missed out on cochlear implantation because of the delay in identifying hearing loss.
Two who were assessed as "normal" by NHS Lothian but were referred for surgery after a second opinion and five had surgery delayed because of a delay in diagnosis.
In the cases of forty-nine children, identification and management of hearing loss was "significantly delayed".
NHS Lothian has now been escalated to stage 3 of the NHS Board Performance Escalation Framework, which means there are risks to patients and tailored support is required and the BAA made 36 recommendations.
Dr Tracey Gillies, Medical Director at NHS Lothian said: “We are very sorry and saddened to learn that there are some children whose conditions were not diagnosed correctly, or as early as possible, as a result of testing that was not up to standard.
“Due to these failings, the diagnosis of hearing loss or impairment in six children was missed.
"Diagnosis of a further six children was significantly delayed with long term consequences for these children.
"Their long-term development of speech and language will be affected and these children will require specialist support.”
“Delayed diagnosis of hearing loss in a further 48 children is also likely to have resulted in some harm, though the longer-term impact of this will depend on the individual circumstances of each child. Some children may require to be retested.
“We have already written to the most severely-affected families individually to offer support and a face-to-face meeting to discuss their child’s condition. We have also arranged appointments for those children whom the review recommends should be tested again.
“In addition, measures have been put in place to identify young children currently in the system whose cases may require clinical review. If any concerns are found, the families will be contacted immediately."
Health Secretary Humza Yousaf said families had been failed by the health board.
He said: "I have already made my views unequivocally clear to NHS Lothian. The service provided to children affected and their families was simply not good enough.
“I expect the Board to enact the recommendations as a matter of urgency and engage with any actions from the formal recovery plan.
“To those families who have been affected by this I would like to extend my heartfelt apologies along with a promise that robust action will be taken."
A dedicated helpline has been set up for affected families (0131 465 547) and further support is being provided by the National Deaf Children Society on 0808 800 8880.
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