![]() 23, 24 The development of auditory perception can be characterized as a hierarchy with discrete levels between sound detection and speech recognition, as the sensory primitives are re-organized into neural representations. At the most basic level, a prosthesis must provide access to sound, or the “sensory primitive”. However, quantifying “auditory” benefit in a very young child is not straightforward, given the complex interaction between electrical sensory input and developing perception, attention, language, and cognition. Intuitively, an auditory prosthesis should provide the sensation of meaningful sound forming the basis for language acquisition. ![]() Performance Assessment of Children with an Auditory Prosthesis 11, 12 This, in turn, produces electrical stimulation patterns for optimal neural synchrony, increasing the potential for “normal” auditory neural pathway development in the young child. The tonotopic arrangement of the cochlea and nerve fibers affords impressive electrical programming flexibility, including targeting stimulation toward the regions transducing specific frequencies. The peripheral auditory nerve is stimulated by converting sound pressure waves into electrical pulses delivered by an external speech processor to a thin, wire-like electrode array, threaded inside the cochlea ( Figure 1a). When the required pre-surgery vaccinations are in place, the child should experience few medical or device-related side effects 10. Implantation is conducted on an outpatient basis. CI indications have expanded from adults deafened after language acquisition to congenitally deaf children as young as 12 months of age. 9 Much more impressive outcomes (safety and efficacy) for 3 advanced multichannel systems (manufacturers: Advanced Bionics, Cochlear Limited, and MED-EL) led to the FDA-approved systems now in widespread use. The first commercially available CI consisted of a single-electrode system. Implantable Auditory Prosthesis: Cochlear Implant 8 The narrative approach allows for wide-ranging discussion of factors throughout the treatment path in very young children. The framework facilitates communication among stakeholders, informs a research agenda for identified knowledge gaps, and sets the context for informed consent discussions. 6 The narrative approach involves integrating information from research within neurosurgery, neurotology, audiology, and education, around 5 key factors: an analysis of the condition, a description of the unmet medical need, a summary of the device’s benefits and risks, including managing those risks 7. A qualitative or narrative framework will be adopted here and applied to decision-making for implantable auditory prostheses in young children. The proposed benefit-risk assessment strategies include both quantitative and qualitative approaches 1, 3– 5. Including consideration of family/patient risk tolerance, and differing levels of outcomes conditioned on disease state provides a more global assessment of the benefits and risks. The structured process for organizing medical condition and treatment information emerged from an appreciation that the approval of new drugs and devices involved factors beyond demonstration of safety and efficacy.
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