An inflatable in-ear device (1) incorporates a pressure regulating mechanism, for example a simple length of tubing (30) or a relief/unloader valve (50), at the inflow or outflow from the inflating sheath (8) inserted within the ear canal (22), thus allowing pressure regulation of the settable compound being injected for inflation of the sheath (8) while avoiding excesses in pressure in the inflating compound and ensuring the comfort of the individual.
