The Challenge
In 2016 the Bose Corporation realized that they could make lower-cost, high quality hearing aids which could be self-fit by the wearer, and sold directly to consumers without the need for prescription, state-by-state regulations, or monopolistic distribution networks. Bose brought on the Alpine Group to advance legislation with the goal of creating a new category of hearing aid – no small task when the dominant 5 manufacturers of hearing aids globally aligned to fight and delay the issuance of regulations, and to restrict the effectiveness and availability of these new devices.
solution
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The Alpine Group advanced legislation to create a new category of hearing aid.
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Alpine created an informal coalition which brought together diverse stakeholders and policymakers across the political spectrum.
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When the dominant 5 manufacturers of hearing aids globally fought to delay the issuance of regulations, and to restrict the effectiveness and availability of these new devices, the Alpine Group pursued a sustained counter effort. Alpine engaged directly with the FDA and senior White House and HHS officials, as well as members of the House and Senate in order to maintain pressure on the FDA to issue the regulations consistent with Congressional intent.
results
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By mid-2017 Congress enacted an over-the-counter hearing aid law over the objections of the incumbent hearing aid industry, gun rights groups, and other organizations intent on protecting the high-cost, low innovation status quo
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In August 2022, the FDA issued the required regulations with provisions to ensure broad consumer access to low cost, high quality hearing aids still intact – and aging rock and rollers across the globe breathed a sigh of relief.