Dataset Information

Effectiveness of a programable body-worn digital hearing aid for older adults in a developing country: a randomized controlled trial with a cross-over design.

ABSTRACT:

Background

Hearing aids are important assistive devices for hearing rehabilitation. However, the cost of commonly available commercial hearing aids is often higher than the average monthly income of individuals in some developing countries. Therefore, there is a great need to locally produce cheaper, but still effective, hearing aids. The Thai-produced P02 hearing aid was designed to meet this requirement.

Objective

To compare the effectiveness of the P02 hearing aid with two common commercially available digital hearing aids (Clip-II™ and Concerto Basic®).

Methods

A prospective, randomized controlled trial with a cross-over design was conducted from October 2012 to September 2014 in a rural Thai community. There were 73 participants (mean age of 73.7 ± 7.3 years) included in this study with moderate to severe hearing loss who were assessed for hearing aid performance, including probe microphone real-ear measurement, functional gain, speech discrimination, and participant satisfaction with the overall quality of perceived sound and the design of the device.

Results

There were no statistically significant differences in functional gain or speech discrimination among the three hearing aids evaluated (p-value > 0.05). Real-ear measurements of the three hearing aids met the target curve in 93% of the participants. The best real-ear measurement of the hearing aid following the target curve was significantly lower than that of Clip-II™ and Concerto Basic® (p-value < 0.05) at high frequency. However, participants rated the overall quality of sound higher for the P02 hearing aid than that of Clip-II™ but lower than that of Concerto Basic® (p-value > 0.05). Participants revealed that the P02 hearing aid provided the highest satisfaction ratings for design and user-friendliness with statistical significance (p-value < 0.05).

Conclusion

The P02 hearing aid was an effective device for older Thai adults with hearing disabilities. Additionally, its modern design, simplicity of use, and ease of maintenance were attractive to this group of individuals. These benefits support the rehabilitation potential of this hearing aid model and its positive impact on the quality of life of older adults in developing countries.

Trial registration

This study was registered under Clinicaltrial.gov NCT01902914 . Date of registration: July 18, 2013.

SUBMITTER: Kasemsiri P

PROVIDER: S-EPMC8299624 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceHearing loss is a highly prevalent condition, with numerous debilitating consequences when left untreated. However, less than 20% of US adults with hearing loss use hearing aids. Over-the-counter (OTC) hearing aids became available in October 2022 to improve access and affordability. However, clinical effectiveness studies of available OTC hearing aids using the existing devices in the market are limited.ObjectiveTo compare the clinical effectiveness of a self-fitting OTC hearing aid with remote support and a hearing aid fitted using audiologist-fitted best practices.Design, setting, and participantsThis randomized clinical effectiveness trial was conducted between April 14 and August 29, 2022. Sixty-eight adults with self-perceived mild to moderate hearing loss were recruited and randomly assigned to either the self-fitting or the audiologist-fitted group. Following bilateral hearing aid fitting, participants first completed a 2-week, take-home field trial without any support. Access to fine-tuning for both groups was only available after the 2-week trial. Support and adjustment were provided remotely for the self-fitting group per request and by the audiologist for the audiologist-fitted group. Participants were then reassessed after an additional 4-week take-home trial.InterventionsA commercially available self-fitting OTC hearing aid was provided to participants in the self-fitting group who were expected to set up the hearing aids using the commercially supplied instructional material and accompanying smartphone application. In the audiologist-fitted group, audiologists fitted the same hearing aid according to the National Acoustics Laboratories nonlinear version 2 algorithm for prescriptive gain target using real-ear verification with hearing aid use instruction.Main outcomes and measuresThe primary outcome measure was self-reported hearing aid benefit, measured using the Abbreviated Profile of Hearing Aid Benefit (APHAB). Secondary measures included the International Outcome Inventory for Hearing Aids (IOI-HA) and speech recognition in noise measured using an abbreviated speech-in-noise test and a digits-in-noise test. All measures were completed at baseline and at 2 intervals following hearing aid fitting (2 and 6 weeks).ResultsSixty-four participants were included in the analytic sample (33 men [51.6%]; mean [SD] age, 63.6 [14.1] years), with equal numbers of participants (n = 32) randomized into each group. The groups did not differ significantly in age (effect size r = -0.2 [95% CI, -0.3 to 0.2]) or 4-frequency pure-tone average (effect size r = 0.2 [95% CI, -0.1 to 0.4]). After the 2-week field trial, the self-fitting group had an initial advantage compared with the audiologist-fitted group on the self-reported APHAB (Cohen d = -0.5 [95% CI, -1.0 to 0]) and IOI-HA (effect size r = 0.3 [95% CI, 0.0-0.5]) but not speech recognition in noise. At the end of the 6-week trial, no meaningful differences were evident between the groups on any outcome measures.Conclusion and relevanceIn this randomized clinical effectiveness trial, self-fitting OTC hearing aids with remote support yielded outcomes at 6 weeks post fitting comparable to those of hearing aids fitted using audiologist best practices. These findings suggest that self-fitting OTC hearing aids may provide an effective intervention for mild to moderate hearing loss.Trial registrationClinicalTrials.gov Identifier: NCT05337748.

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