Quality

The WHO preferred product profile provides guidance on quality but is not designed to be a rigorous quality standard. Many products match the WHO preferred product profile on paper, but in practice have poorer sound quality, are not durable, or are difficult to programme by the provider. There are no existing or planned standards for hearing aids that provide an objective measure of quality to inform procurement for low- resource settings. According to experts, the US FDA and CE marks are not able to differentiate quality from non-quality products on the measure of hearing quality, and there is no globally recognized quality-testing programme. The FDA requires certification of gains and output of hearing aids through a third-party agency to ensure they match specifications, but this process is not a quality certification. Hearing aids are tested for quality at four levels but clinical tests for quality are not conducted at a global level, which deters transparency on product quality.

78

Table 33: Existing quality standards and gaps at the global level

Test type What does it test for? Testing organization Information available publicly
Manufacturing plant tests ISO 13845: Whether plant follows manufacturing standards and protocols. United States FDA Yes
Engineering tests Whether hearing aids can perform acoustically according to their specifications. For example: can it amplify sounds higher than 80dB? Can it reduce background noise effectively? United States FDA, European Union CE (Conformité europénne), and National Health Service United Kingdom (NHS UK) Yes
Durability tests Whether the product is durable. For example, drop test, climate test (moisture/dust/heat), etc. United States FDA, European Union CE (Conformité europénne), and National Health Service United Kingdom (NHS UK) Yes
Clinical tests Test user experience of sound quality; provider experience with fitting and provision; longer- term performance and reliability Independent procurers such as the United Kingdom National Health Service, International Humanitarian Hearing Aid Purchasing Programme (IHHAPP); independent audiologists conducting field testing No

There is a need to establish quality testing derived from high-income countries’ public procurer models, mirroring product selection approaches from other product areas.

79